New study ties weight-loss drugs Wegovy, Ozempic to serious gastrointestinal conditions

Issues like pancreatitis, stomach paralysis higher among patients using glp-1 inhibitor medications.

A pharmacist holds two boxes of Ozempic.

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Medicines in the same class as Novo Nordisk's popular weight-loss therapy Wegovy may carry an increased risk of pancreatitis, intestinal blockage and stomach paralysis compared to an older obesity drug, according to a study published on Thursday.

The study focused on two drugs from the class known as GLP-1 inhibitors, which help lower blood sugar levels for people with Type 2 diabetes: semaglutide is the active ingredient in Wegovy as well as Novo's diabetes drugs Ozempic and Rybelsus; liraglutide is the active ingredient in the company's earlier obesity medicine Saxenda and diabetes drug Victoza.

Nearly five in every 1,000 users of semaglutide drugs developed pancreatitis, compared to one of every 1,000 users of bupropion-naltrexone, the active ingredients in the weight-loss drug Contrave, according to a report in the JAMA medical journal . Contrave was approved in the U.S. in 2014 and in Canada in 2018.

For liraglutide, there were about eight cases of pancreatitis per 1,000 users.

Pancreatitis, or inflammation of the pancreas, can cause severe abdominal pain.

For stomach paralysis, researchers found roughly nine cases among every 1,000 users of semaglutide and about seven in liraglutide patients, compared with three among the same number of those taking bupropion-naltrexone.

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GLP-1 inhibitor medications mimic the actions of GLP-1, a natural hormone that helps control blood sugar levels in people with diabetes.

Mahyar Etminan, an epidemiologist at the University of British Columbia and senior author of the study, said up to two per cent of patients who used semaglutide and liraglutide medications to lose weight developed gastrointestinal problems.

"When you have millions of people taking them, that one per cent starts becoming a relatively big number," he said. "One of my main concerns is that they're long-term adverse events for which we really don't have much data, especially for those who are taking them just for weight loss and not for diabetes."

People with diabetes were not included in the study.

The study was observational, so it can only show associations, not whether the drugs caused the conditions. 

Weight management doctors in Canada, who've also done work for the drug companies, say the findings make sense.

"When we look at a medication that works at a much higher level and causes much more weight loss, we're going to see more side-effects," said Dr. Sean Wharton, an internal medical physician in Toronto.

Health Canada says it will review the new study along with others to determine whether safety warnings need to be updated. 

The results of this study are consistent with effects observed in clinical trials in obese patients, said Penny Ward, an independent pharmaceutical physician and visiting professor in pharmaceutical medicine at King's College London in the U.K.

Ward told Science Media Centre  that the study wasn't designed to assess all possible side-effects of the treatments. 

"All of this information suggests that these agents should be used with care and only among patients at greatest risk of poor health or obesity-related complications that have been appropriately counselled about their risks," Ward said.

G.I. warnings in U.S.

A Novo Nordisk spokesperson cited limitations of the study that might skew the results, including a failure to fully consider patients' risk factors for gastrointestinal disorders.

The data also was collected between 2006 and 2020, before Wegovy was approved in the U.S. in 2021.

Novo Nordisk and Eli Lilly, whose GLP-1 diabetes drug Mounjaro is expected to be approved for weight loss this year, are facing several lawsuits in the U.S. accusing them of failing to warn users of the risks of severe stomach paralysis associated with the medicines.

  • Shortage of diabetes, weight-loss drug Ozempic expected in Canada, says manufacturer
  • THE CURRENT Canadians are taking Ozempic, but stigma around weight stops them talking about it

GLP-1 drugs like Wegovy slow the passage of food through the stomach, helping people feel fuller longer. Problems can occur if stomach-emptying slows too much.

The U.S. Food and Drug Administration has recorded 209 incidents of Wegovy patients suffering from gastrointestinal disorders this year, 42 of whom were hospitalized.

Last month, the FDA updated the label for Ozempic to warn of the potential for intestinal blockage, which is already listed as a side-effect for Wegovy and Mounjaro.

The Institute for Safe Medication Practices Canada issued a bulletin last week after a patient who had been taking weekly semaglutide injections for weight loss vomited a large volume of undigested food while waking from anesthesia following orthopedic surgery.

With files from The Canadian Press and CBC News

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  • Published: 10 October 2022

Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial

  • W. Timothy Garvey   ORCID: orcid.org/0000-0003-0822-0860 1 ,
  • Rachel L. Batterham   ORCID: orcid.org/0000-0002-5477-8585 2 , 3 , 4 ,
  • Meena Bhatta 5 ,
  • Silvio Buscemi   ORCID: orcid.org/0000-0003-0730-7649 6 , 7 ,
  • Louise N. Christensen 5 ,
  • Juan P. Frias 8 ,
  • Esteban Jódar   ORCID: orcid.org/0000-0002-1234-8560 9 ,
  • Kristian Kandler   ORCID: orcid.org/0000-0003-0686-0549 5 ,
  • Georgia Rigas 10 ,
  • Thomas A. Wadden 11 ,
  • Sean Wharton 12 &

the STEP 5 Study Group

Nature Medicine volume  28 ,  pages 2083–2091 ( 2022 ) Cite this article

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  • Drug therapy

The STEP 5 trial assessed the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo (both plus behavioral intervention) for long-term treatment of adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes. The co-primary endpoints were the percentage change in body weight and achievement of weight loss of ≥5% at week 104. Efficacy was assessed among all randomized participants regardless of treatment discontinuation or rescue intervention. From 5 October 2018 to 1 February 2019, 304 participants were randomly assigned to semaglutide 2.4 mg ( n  = 152) or placebo ( n  = 152), 92.8% of whom completed the trial (attended the end-of-trial safety visit). Most participants were female (236 (77.6%)) and white (283 (93.1%)), with a mean (s.d.) age of 47.3 (11.0) years, body mass index of 38.5 (6.9) kg m –2 and weight of 106.0 (22.0) kg. The mean change in body weight from baseline to week 104 was −15.2% in the semaglutide group ( n  = 152) versus −2.6% with placebo ( n  = 152), for an estimated treatment difference of −12.6 %-points (95% confidence interval, −15.3 to −9.8; P  < 0.0001). More participants in the semaglutide group than in the placebo group achieved weight loss ≥5% from baseline at week 104 (77.1% versus 34.4%; P  < 0.0001). Gastrointestinal adverse events, mostly mild-to-moderate, were reported more often with semaglutide than with placebo (82.2% versus 53.9%). In summary, in adults with overweight (with at least one weight-related comorbidity) or obesity, semaglutide treatment led to substantial, sustained weight loss over 104 weeks versus placebo. NCT03693430

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Behavioral intervention incorporating modifications in diet and physical activity remains the foundation of treatment for overweight and obesity. However, because behavioral intervention is often not associated with clinically meaningful and sustainable weight loss, pharmacotherapy is recommended as an additional tool for long-term weight management in people with a body mass index (BMI) of at least 30 kg m –2 , or at least 27 kg m –2 in those with weight-related comorbidities 1 .

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog approved for the treatment of type 2 diabetes (oral semaglutide and subcutaneous semaglutide) and for reducing the risk of cardiovascular events in people with type 2 diabetes and cardiovascular disease (subcutaneous semaglutide only) 2 , 3 , 4 , 5 . At a dose of 2.4 mg once-weekly, subcutaneous semaglutide was approved in the United States, Europe, the United Kingdom and Canada for weight management in adults with overweight (BMI ≥ 27 kg m –2 with at least one weight-related comorbidity) or obesity (BMI ≥ 30 kg m –2 ) 2 , 3 , 4 , 5 , based on results from the Semaglutide Treatment Effect in People with Obesity (STEP) clinical trial program. In the STEP 1 and 3 trials in participants without type 2 diabetes, average placebo-subtracted weight losses of 12.4% and 10.3%, respectively, were seen with semaglutide 2.4 mg at week 68 (refs. 6 , 7 ).

Previous studies in the STEP trial program have been limited to treatment durations of up to 68 weeks 6 , 7 , 8 . The 2-year STEP 5 study reported herein was conducted to evaluate the long-term effect of once-weekly subcutaneous semaglutide 2.4 mg compared with placebo, as an adjunct to behavioral intervention, on body weight and cardiometabolic risk factors, in adults with obesity (BMI ≥ 30 kg m –2 ), or with overweight (BMI ≥ 27 kg m –2 ) and at least one weight-related comorbidity, without diabetes (Extended Data Fig. 1 ). This phase 3, randomized, double-blind, placebo-controlled, multinational trial represents the longest study of the use of semaglutide for weight management to date. Co-primary endpoints were percentage change in body weight from baseline to week 104 and achievement of weight loss of at least 5% of baseline weight at week 104.

Participants and treatment

From 5 October 2018 to 1 February 2019, 304 participants were randomly assigned to semaglutide 2.4 mg ( n  = 152) or placebo ( n  = 152) and included in the full analysis set (all randomized participants according to the intention-to-treat principle). Observation periods included the in-trial period (that is, while in the trial, regardless of treatment discontinuation or rescue intervention) and the on-treatment period (with trial product). Overall, of 304 participants, 282 (92.8%) completed the trial (attended the end-of-trial safety visit), 272 (89.5%) had a body weight assessment at the end-of-treatment visit at week 104, and 243 (79.9%) adhered to treatment (were on-treatment at the end-of-treatment visit) (Fig. 1 ).

figure 1

s.c., subcutaneous.

Demographics and baseline characteristics were similar between groups (Table 1 ). Most participants were female (236 (77.6%) of 304) and most were white (283 (93.1%) of 304). Mean age was 47.3 years. Mean body weight was 106.0 kg and mean BMI was 38.5 kg m –2 .

Two estimands were employed for the assessment of efficacy endpoints—estimands assess treatment efficacy from different perspectives and account for intercurrent events (for example, discontinuation of trial product or initiation of other weight loss interventions) and missing data differently. The ‘treatment policy’ estimand quantified the treatment effect for the in-trial period among all randomly assigned participants, regardless of treatment discontinuation or rescue intervention, based on the intention-to-treat principle, and was used as the primary analysis method. The ‘trial product’ estimand quantified the average treatment effect for the on-treatment period in all randomly assigned participants, assuming that the drug or placebo was taken as intended, and was used as the secondary analysis method ( Methods ).

Efficacy endpoint results for the treatment policy estimand

Mean observed change in body weight over time during the in-trial period is shown as percentage change in Fig. 2a and as absolute change (kg) in Extended Data Fig. 2 . Based on the treatment policy estimand, the estimated mean (standard error (s.e.)) change in body weight from baseline to week 104 was –15.2% (0.9) with semaglutide and –2.6% (1.1) with placebo (co-primary endpoint; estimated treatment difference (ETD) –12.6 percentage points, 95% confidence interval (CI) –15.3 to –9.8, P  < 0.0001). Semaglutide-treated participants, compared with placebo, were more likely to lose at least 5% of baseline body weight at week 104 (co-primary endpoint; odds ratio (OR) 5.0, 95% CI 3.0 to 8.4; P  < 0.0001). At week 104, 111 (77.1%) versus 44 (34.4%) participants in the semaglutide and placebo groups, respectively, were observed to have achieved this endpoint (in-trial period data; among 144 participants for semaglutide and 128 for placebo) (Table 2 and Fig. 2b ). As statistical superiority for both co-primary endpoints was demonstrated for semaglutide versus placebo, the prespecified criteria for a positive trial were met, indicating a significant benefit of semaglutide versus placebo.

figure 2

a , Observed mean percentage change from baseline in body weight over time for participants in the full analysis set during the in-trial observation period (error bars are standard error of the mean; numbers below the panels are the number of participants contributing to the mean) and estimated treatment difference for the percentage change from baseline to week 104 in body weight based on the treatment policy estimand. b , Observed proportions of participants and OR for achieving weight loss of at least 5% from baseline at week 104 in the full analysis set during the in-trial observation period, based on the treatment policy estimand. *Estimated means in percent are from the primary analysis. The in-trial observation period was the time from random assignment to last contact with a trial site, regardless of treatment discontinuation or rescue intervention. The treatment policy estimand assesses treatment effect regardless of treatment discontinuation or rescue intervention; see Extended Data Fig. 6 for corresponding data for the trial product estimand (which assesses treatment effect assuming all participants adhered to treatment and did not receive rescue intervention). The change in body weight analysis was conducted with the use of the analysis-of-covariance method, with randomized treatment as a factor and baseline body weight as a covariate. The achievement of at least 5% weight loss analysis was conducted with the use of logistic regression, with the same factor and covariate. A multiple imputation approach was used for missing data. The results were accompanied by two-sided 95% CIs and corresponding P values (significance defined as P  < 0.05). As co-primary endpoints, the analyses were controlled for multiple comparisons.

Semaglutide-treated participants, compared with placebo, were also more likely to lose at least 10%, 15% or 20% of baseline body weight at week 104 ( P  < 0.0001 for the OR for the 10% and 15% thresholds (both were confirmatory secondary endpoints); the 20% threshold (a supportive secondary endpoint) was not part of statistical testing hierarchy). For the in-trial observation period, these weight loss thresholds were achieved by 89 (61.8%), 75 (52.1%) and 52 (36.1%) of 144 participants in the semaglutide group versus 17 (13.3%), nine (7.0%) and three (2.3%) of 128 participants in the placebo group, respectively (Table 2 and Extended Data Fig. 3 for cumulative distribution of change from baseline).

Semaglutide was associated with greater reductions from baseline to week 104 in waist circumference (–14.4 cm (0.9) with semaglutide versus –5.2 cm (1.2) with placebo; ETD –9.2 cm, 95% CI –12.2 to –6.2, P  < 0.0001) and systolic blood pressure (–5.7 mmHg (1.1) with semaglutide versus –1.6 (1.2) with placebo; ETD –4.2 mmHg, 95% CI –7.3 to –1.0; P  = 0.01) (both were confirmatory secondary endpoints; Table 2 , Fig. 2 and Extended Data Fig. 4a,b ). Compared with placebo, semaglutide also led to improvements in diastolic blood pressure, glycated hemoglobin (HbA 1c ), fasting plasma glucose, fasting serum insulin, C-reactive protein, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol and triglycerides (all were supportive secondary endpoints; Table 2 and Extended Data Fig. 4c,d ).

Of the participants with prediabetes at baseline who also had a glycemic status assessment at week 104, 59 (79.7%) of 74 treated with semaglutide reverted to normoglycemia at week 104, compared with 20 (37.0%) of 54 participants on placebo (an exploratory endpoint; Table 2 and Extended Data Fig. 5 ). Of the participants with normoglycemia at baseline who also had a glycemic status assessment at week 104, one (1.4%) of 71 treated with semaglutide had prediabetes at week 104, compared with 10 (13.0%) of 77 participants on placebo. Among participants with a week 104 assessment, none in the semaglutide group and three in the placebo group had type 2 diabetes at week 104 (one had normoglycemia at baseline and two had prediabetes at baseline). The proportion of participants with changes in the use of lipid-lowering and antihypertensive medication (among those receiving such medications during the trial) is reported in Table 2 (both were exploratory endpoints).

Efficacy endpoint results for the trial product estimand

Mean observed change in body weight over time during the on-treatment period is shown in Extended Data Fig. 6a . For the trial product estimand, the estimated mean (s.e.) change in body weight from baseline to week 104 was –16.7% (0.9) with semaglutide and –0.6% (0.9) for placebo (ETD –16.0 percentage points, 95% CI –18.6 to –13.5). Semaglutide-treated participants, compared with placebo, were more likely to lose at least 5% of baseline body weight at week 104 (OR 18.1 (95% CI 10.0 to 32.5). At week 104, 110 (83.3%) versus 38 (34.9%) participants in the semaglutide and placebo groups, respectively, were observed to have achieved this endpoint (on-treatment period data; among 132 participants for semaglutide and 109 for placebo) (Supplementary Table 1 and Extended Data Fig. 6b ). Results of analyses of the confirmatory and selected supportive secondary endpoints for the trial product estimand, are provided in Supplementary Table 1 .

Safety and tolerability

Adverse events leading to discontinuation of trial product were reported by nine participants (5.9%) in the semaglutide group and seven participants (4.6%) in the placebo group (Table 3 ).

Gastrointestinal disorders, namely nausea, diarrhea, vomiting and constipation, were the most frequently reported adverse events and occurred in more participants treated with semaglutide than with placebo (125 (82.2%) of 152 versus 82 (53.9%) of 152, respectively) (Table 3 ). Most gastrointestinal adverse events were mild-to-moderate and transient, and such events led to permanent treatment discontinuation in six (3.9%) participants in the semaglutide group and one (0.7%) participant in the placebo group (Table 3 and Extended Data Fig. 7 ).

Serious adverse events were reported by 12 (7.9%) of 152 participants in the semaglutide group and 18 (11.8%) of 152 participants in the placebo group (Table 3 ). One death was reported in the semaglutide group and was considered by the independent external event adjudication committee to be unrelated to the trial product (Table 3 ). In the semaglutide versus placebo groups, gallbladder-related disorders were reported by four (2.6%) versus two (1.3%) participants and malignant neoplasms were reported by two (1.3%) versus four (2.6%), respectively (Table 3 ; details on malignant neoplasms are shown in Supplementary Table 2 ). There were no reports of pancreatitis in either treatment group. Additional safety variables are described in Table 3 and Supplementary Table 3 . COVID-19 infection was reported by 16 (10.5%) of 152 participants in the semaglutide group versus eight (5.3%) of 152 participants in the placebo group, with very few cases in each group classed as serious and none requiring temporary or permanent interruption of semaglutide treatment.

In STEP 5, once-weekly treatment with semaglutide 2.4 mg as an adjunct to behavioral intervention in adults with overweight (with at least one weight-related comorbidity) or obesity led to a substantial initial reduction in weight, which plateaued after approximately week 60 and was maintained for the remainder of the study. At week 104, participants in the semaglutide group had achieved a mean weight loss of 15.2% from baseline—a difference of 12.6 percentage points versus placebo plus behavioral intervention. This weight loss is comparable to the mean reduction of 14.9% (placebo-corrected weight loss of 12.4 percentage points) seen at week 68 in the STEP 1 trial of semaglutide 2.4 mg versus placebo (both plus behavioral intervention) 7 . Thus, our findings indicate that the substantial weight losses reported during 68 weeks’ treatment with semaglutide 2.4 mg in prior STEP trials 6 , 7 , 9 can be maintained with continued semaglutide treatment up to at least 104 weeks. The mean weight loss of ~15% achieved with semaglutide 2.4 mg at week 104 in STEP 5 exceeds weight loss reported at similar time points in trials with other pharmacotherapies for weight management in adults with overweight or obesity 10 , 11 , 12 , 13 , 14 .

Weight loss of ≥5%, a threshold widely used to indicate a clinically meaningful response to therapy 15 , was achieved by >75% of participants in the semaglutide group at week 104. Moreover, 61.8% of participants on semaglutide lost ≥10% of baseline weight, and over a third of participants had achieved at least 20% weight loss at week 104 in the semaglutide group. As was seen in prior studies 6 , 7 , 9 , 16 , while the vast majority of participants receiving semaglutide 2.4 mg had lost weight at the end of the STEP 5 study, a small proportion of participants experienced weight gain. We do not know how weight would have changed in these participants had they not been receiving the drug; notably, the proportion of patients with weight gain during the study was substantially higher in the placebo group. There is marked variability in weight change in patients on weight management treatments; the reason for this is still unclear and likely involves complex biological and societal influences.

Obesity is a chronic, relapsing disease that requires continuous effort to control 6 , 17 . With all nonsurgical interventions and to some extent with bariatric surgery, weight regain after initial weight loss is common 10 , 11 , 12 , 13 , 14 , 18 , 19 , 20 , 21 , 22 . In contrast to findings with behavioral 20 , 21 , 22 and other pharmacological interventions 10 , 12 , 13 , the similar mean weight loss achieved with semaglutide 2.4 mg in STEP 5 at weeks 52 and 104 (–15.6% and –15.2%, respectively) suggests that, on average, there is minimal weight regain over 104 weeks when once-weekly semaglutide therapy is continued. When interpreted together with the findings of the STEP 4 withdrawal trial and STEP 1 off-treatment extension study, which both showed weight regain after semaglutide discontinuation (after 20 weeks’ treatment in STEP 4 and 68 weeks’ treatment in STEP 1) 23 , 24 , these results support the benefit of continued semaglutide treatment for sustained weight loss.

Prior 68-week trials in adults with overweight or obesity have reported cardiometabolic improvements with semaglutide 2.4 mg (refs. 6 , 7 , 9 , 16 ). Consistent with these findings, in STEP 5 semaglutide treatment improved a range of cardiometabolic risk parameters, including waist circumference, systolic and diastolic blood pressure, HbA 1c levels, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol and triglycerides. Collectively, these results indicate a beneficial effect of treatment on overall patient health. In addition, semaglutide treatment reduced C-reactive protein levels, a marker of systemic inflammation that is known to be elevated in patients with obesity 25 , 26 . The reduction in fasting insulin and glucose with semaglutide is indicative of an increase in insulin sensitivity. Similar to the findings of other studies in the STEP trial program 7 , 27 , exploratory outcomes showed that in the semaglutide group 80% of participants with prediabetes at baseline reverted to normoglycemia by the end of the trial (compared with 37% of those receiving placebo), while 99% of participants with normoglycemia at baseline maintained normoglycemia at the end of the trial (compared with 86% with placebo). These findings suggest a potential beneficial effect of semaglutide on glycemic status, but whether semaglutide treatment delays or prevents progression to type 2 diabetes requires confirmation. In the 68-week trials 7 , 9 , reductions in weight, waist circumference, blood pressure and HbA 1c appeared to plateau around week 60 with semaglutide. STEP 5 shows that the changes in these parameters were sustained through 104 weeks’ treatment.

The safety profile of semaglutide 2.4 mg in STEP 5 was consistent with that in other STEP program trials 6 , 7 , 9 , 16 , 23 , and with the GLP-1 receptor agonist class in general 28 . Gastrointestinal disorders were the most common adverse events with semaglutide, typically transient, of mild-to-moderate severity, occurring during dose escalation, and infrequently leading to treatment discontinuation.

Strengths of STEP 5 include the high rates of adherence to treatment and completion of the trial (which contributed to consistency in findings between the two estimands). Limitations include the low proportion of nonwhite participants and the preponderance of female participants. In addition, while the homogenous nature of the prescribed dietary intake deficit, physical activity goal and counseling frequency provided consistency, it may not fully reflect the need for approaches tailored to the health profiles of individuals or to different populations in clinical practice; however, beyond adherence to the stipulated criteria for counseling on diet and physical activity, behavioral intervention was delivered by each study site with no further direction, allowing a degree of local tailoring and aiding real-world applicability.

In conclusion, treatment with once-weekly subcutaneous semaglutide in conjunction with behavioral intervention in adults with overweight (with at least one weight-related comorbidity) or obesity (without diabetes) was associated with clinically impactful and sustained weight loss of 15.2% at week 104, along with improvements in weight-related cardiometabolic risk factors.

Trial design and participants

This phase 3, randomized, double-blind, placebo-controlled study was conducted at 41 sites across five countries (Canada, Italy, Hungary, Spain and the United States), as described in a previous publication 8 and listed in the Supplementary information . Most investigators specialized in endocrinology and internal medicine, with others specializing in family medicine, psychiatry and clinical psychology. The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by independent ethics committees or institutional review boards at each study site (a redacted protocol is provided separately).

Participants were eligible to be included in the trial only if all of the following criteria applied:

Informed consent obtained before any trial-related activities. Trial-related activities were any procedures that were carried out as part of the trial, including activities to determine suitability for the trial.

Male or female, aged ≥18 years at the time of signing informed consent.

BMI ≥ 30.0 kg m – 2 or ≥27.0 kg m –2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.

History of at least one self-reported unsuccessful dietary effort to lose body weight.

Participants were excluded from the trial if any of the following criteria applied:

Glycemia-related

HbA 1c  ≥ 48 mmol mol –1 (6.5%) as measured by the central laboratory at screening.

History of type 1 or type 2 diabetes.

Treatment with glucose-lowering agent(s) within 90 days before screening.

Obesity-related

A self-reported change in body weight >5 kg (11 lbs) within 90 days before screening irrespective of medical records.

Treatment with any medication for the indication of obesity within the past 90 days before screening.

Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening; (2) lap banding, if the band had been removed >1 year before screening; (3) intragastric balloon, if the balloon had been removed >1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed >1 year before screening.

Uncontrolled thyroid disease, defined as thyroid-stimulating hormone >6.0 mIU l –1 or <0.4 mIU l –1 as measured by the central laboratory at screening.

Mental health

History of major depressive disorder within 2 years before screening.

Diagnosis of other severe psychiatric disorder (for example, schizophrenia, bipolar disorder).

A Patient Health Questionnaire-9 score of ≥15 at screening.

A lifetime history of a suicidal attempt.

Suicidal behavior within 30 days before screening.

Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 30 days before screening.

General safety

Presence of acute pancreatitis within the past 180 days before the day of screening.

History or presence of chronic pancreatitis.

Calcitonin ≥100 ng l –1 as measured by the central laboratory at screening.

Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Renal impairment measured as estimated glomerular filtration rate value of <15 ml min 1.73 m –2 as defined by KDIGO 2012 (ref. 30 ) by the central laboratory at screening.

History of malignant neoplasms within the past 5 years before screening. Basal and squamous cell skin cancer and any carcinoma in situ were allowed.

Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 60 days before screening.

Participant classified as being in New York Heart Association Class IV.

Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.

Known or suspected abuse of alcohol or recreational drugs.

Known or suspected hypersensitivity to trial product(s) or related products.

Previous participation in the trial. Participation was defined as signed informed consent.

Participation in another clinical trial within 90 days before screening.

Other person(s) from the same household participating in any semaglutide trial.

Female who was pregnant, breast-feeding, or intended to become pregnant, or was of child-bearing potential and not using a highly effective contraceptive method.

Any disorder, unwillingness or inability not covered by any of the other exclusion criteria which, in the investigator’s opinion, might have jeopardized the participant’s safety or compliance with the protocol.

Randomization and masking

Randomization (1:1) to semaglutide 2.4 mg or placebo was done centrally by the clinical research organization (Parexel) in a double-blind manner using an interactive web-based response system (IWRS) with a fixed-size blocking schema, without stratification. The IWRS generated the randomization list and assigned patients to the next available treatment according to the randomization schedule. The IWRS allocated dispensing unit numbers for each patient, with the trial product dispensed by the site investigator or study coordinator at the trial site visits. The active product and corresponding placebo product were visually identical to maintain masking of participants and site staff. The people analyzing the data were blinded to treatment/group assignment until breaking the blinding at database lock.

Participants received subcutaneous semaglutide 2.4 mg or placebo once-weekly for 104 weeks, in addition to standard behavioral intervention, followed by 7 weeks without treatment. Semaglutide was initiated at 0.25 mg per week for the first 4 weeks via a pre-filled pen injector, escalating in a fixed-dose regimen every 4 weeks to reach the maintenance dose of 2.4 mg by week 16 (lower maintenance doses were permitted if participants were unable to tolerate 2.4 mg) (Extended Data Fig. 1 ). Behavioral intervention consisted of counseling by a dietitian or similarly qualified healthcare professional every 4 weeks via in-person visits or telephone on adherence to a reduced-calorie diet (500 kcal deficit a day relative to the energy expenditure estimated at randomization) and increased physical activity (150 minutes a week encouraged, for example, walking), both recorded daily (via a diary, app or other tools, which were reviewed during counseling sessions); beyond these criteria for behavioral intervention, no further standardization of behavioral intervention was applied across study sites. Participants discontinuing treatment prematurely remained in the trial and were encouraged to attend scheduled visits, particularly those at weeks 104 and 111.

Body weight, waist circumference and vital signs (systolic and diastolic blood pressure and pulse) were measured at baseline; these measurements were repeated every 4 weeks until week 20, and every 8 weeks thereafter, until week 100 and week 104 (within 3 days either side of scheduled visit day). These parameters were also measured at the end-of-trial visit at week 111 (within 5 days either side of scheduled visit day). Height was measured at screening. HbA 1c , fasting plasma glucose, lipids and C-reactive protein were measured at baseline and weeks 20, 52, 84, and 104; electrocardiograms were also performed at these time points. Fasting serum insulin was measured at baseline and week 104. Physical examinations were performed at screening and weeks 52 and 104. Hematology and biochemistry laboratory parameters were measured at screening and weeks 20, 52, 84 and 104. Adverse events were recorded at each visit. Control of eating was assessed in a subset of participants from the United States and Canada; these results will be presented in a separate manuscript.

Given the emergence of COVID-19 in the second year of the study, trial visits were permitted to be conducted via telephone, during which counseling was provided and safety-related information was collected; endpoint assessments were not performed during telephone visits. Assessment data were collected at the next possible in-person visit.

Co-primary endpoints were percentage change in body weight from baseline to week 104 and achievement of weight loss of at least 5% of baseline weight at week 104. These were tested first in the statistical testing hierarchy, followed by the confirmatory secondary endpoints, which were tested in the following order: achievement of weight loss of at least 10% or 15% at week 104; and change from baseline to week 104 in waist circumference and systolic blood pressure.

Supportive secondary endpoints were not included in the statistical testing hierarchy and were: achievement of weight loss of ≥20% at week 104; change from baseline to week 104 in body weight (in kg), BMI, HbA 1c , fasting plasma glucose, fasting serum insulin, diastolic blood pressure, lipids (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, free fatty acids and triglycerides) and C-reactive protein; change from baseline to week 52 in body weight (percentage change and kg change), BMI and waist circumference; and achievement of weight loss of ≥5%, ≥10%, ≥15% and ≥20% at week 52.

Exploratory endpoints reported herein include change from baseline to week 104 in glycemic category, antihypertensive medication use and lipid-lowering medication use. Glycemic category (normoglycemia, prediabetes or type 2 diabetes) was determined by investigators on the basis of available information (for example, medical records, concomitant medication, and blood glucose variables) and in accordance with American Diabetes Association criteria 30 , which for prediabetes includes fasting plasma glucose levels of 100 mg dl –1 (5.6 mmol l –1 ) to 125 mg dl –1 (6.9 mmol l –1 ) or HbA 1c levels of 5.7–6.4% (39–47 mmol l –1 ), and for type 2 diabetes includes fasting plasma glucose levels of ≥126 mg dl –1 (7.0 mmol l –1 ) or HbA 1c levels ≥6.5% (48 mmol l –1 ). The allowance for investigators to use all available information (for example, concomitant medication) to assess glycemic category was primarily included to account for scenarios in which glucose-lowering medications were initiated during the trial that would confound glycemic category assessment if based purely on fasting plasma glucose or HbA 1c levels (for example, if a patient developed diabetes during the study and received a glucose-lowering drug that resulted in their glucose level being below the American Diabetes Association threshold for type 2 diabetes diagnosis). Additional exploratory endpoints for which data are not reported were: permanent discontinuation of trial product between baseline and week 104; time to permanent discontinuation of trial product; and Control of Eating Questionnaire scores from the four domains and 19 individual items (applicable for United States and Canada only).

Safety endpoints included the number of treatment-emergent adverse events and serious adverse events, assessed between baseline and week 111; and change from baseline to week 104 in pulse, amylase, lipase and calcitonin. An independent external event adjudication committee reviewed cardiovascular events, acute pancreatitis and deaths.

Statistical analysis

A sample size of 300 participants provided an effective power of at least 96% for the two co-primary endpoints, and at least 43% for all confirmatory secondary endpoints, which were tested in a predefined hierarchical order (Supplementary Table 4 ). The two co-primary endpoints were analyzed independently of each other, and for the trial to be considered to be positive (indicating a significant benefit of semaglutide versus placebo), statistical superiority for both co-primary endpoints was required to be demonstrated.

Efficacy endpoints were analyzed using the full analysis set (all randomized participants according to the intention-to-treat principle). Safety endpoints were analyzed using the safety analysis set of all randomized participants exposed to at least one dose of randomized treatment. Observation periods included the in-trial period (that is, while in the trial, regardless of treatment discontinuation or rescue intervention) and the on-treatment period (with trial product). All results from statistical analyses of confirmatory endpoints were accompanied by two-sided 95% CIs and corresponding P values (significance defined as P  < 0.05). Supportive secondary endpoint analyses were not controlled for multiple comparisons and should not be used to infer definitive treatment effects.

Two estimands were employed to assess treatment efficacy from different perspectives and accounted for intercurrent events and missing data differently, as described in a previous publication 31 . The treatment policy estimand quantified the treatment effect among all randomly assigned participants, regardless of treatment discontinuation or rescue intervention (participants in trial; intention to treat). This estimand was used to assess the superiority of semaglutide versus placebo for the co-primary and confirmatory secondary endpoints in a predefined hierarchical order.

For the treatment policy estimand, continuous endpoint analyses were conducted with the use of the analysis-of-covariance method, with randomized treatment as a factor and baseline endpoint value as a covariate. Analyses of categorical endpoints were conducted with the use of logistic regression, with the same factor and covariate. A multiple imputation approach was used to handle missing data 31 , with imputation based on available data from participants in the same treatment arm with the same treatment status (on-treatment or discontinued). Imputation was performed using a linear regression model, with sex, baseline BMI and timing of last observation as factors, and baseline value and last observation value as covariates. One thousand complete datasets were generated for analysis, with results combined using Rubin’s formula.

The trial product estimand addressed the average treatment effect in all randomly assigned participants, assuming that the drug or placebo was taken as intended (participants on treatment). For the trial product estimand, continuous endpoint analyses were conducted using a mixed model for repeated measures with randomized treatment as a factor and baseline endpoint value as a covariate. Analyses of categorical endpoints were conducted with the use of logistic regression, with categorization for missing data based on values predicted from the mixed model for repeated measures. Analyses of endpoints for the trial product estimand were not adjusted for multiplicity.

Statistical analyses were performed using SAS version 9.4 (SAS Institute Inc.). Additional details on analytic methods per endpoint are in Supplementary Table 4 . Exploratory endpoints were assessed with descriptive statistics based on observed data.

The trial is closed and completed. The study is registered with ClinicalTrials.gov, NCT03693430 .

Reporting summary

Further information on research design is available in the Nature Research Reporting Summary linked to this article.

Data availability

Data will be shared with bona fide researchers submitting a research proposal approved by the independent review board. The research proposal must outline: the scientific rationale and relevance of the proposed research; a short lay summary intended for public disclosure; research methodology and data; statistical analysis plan and publication plan. Data must not be used for commercial purposes. Data will be made available after research completion, and approval of the product and product use in the European Union and the USA. Individual participant data will be shared in datasets in a de-identified and anonymized format. Access request proposals can be found at novonordisk-trials.com.

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Acknowledgments

We thank the study participants, and the investigators and study site staff who conducted the study. In addition, we thank N. Beadle of Axis, a division of Spirit Medical Communications Group Limited, for medical writing and editorial assistance (funded by Novo Nordisk A/S, Denmark). The study was funded by Novo Nordisk. The funder designed the trial, oversaw its conduct, monitored trial sites, and collected and analyzed the data; investigators were responsible for trial-related medical decisions and data collection. This article was drafted under the guidance of the authors, with medical writing and editorial support paid for by the funder.

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Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA

  • W. Timothy Garvey

University College London Centre for Obesity Research, Division of Medicine, University College London, London, UK

Rachel L. Batterham

National Institute of Health Research, UCLH Biomedical Research Centre, London, UK

Centre for Weight Management and Metabolic Surgery, University College London Hospital, London, UK

Novo Nordisk A/S, Søborg, Denmark

Meena Bhatta, Louise N. Christensen & Kristian Kandler

Unit of Clinical Nutrition, Policlinico University Hospital, Palermo, Italy

Silvio Buscemi

Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy

National Research Institute, Los Angeles, CA, USA

Juan P. Frias

Department of Endocrinology and Nutrition, Hospital Universitario QuironSalud Madrid, Universidad Europea de Madrid, Madrid, Spain

Esteban Jódar

Department of Bariatric Metabolic Surgery, St George Private Hospital, Kogarah, Sydney, Australia

Georgia Rigas

Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Thomas A. Wadden

York University, McMaster University and Wharton Weight Management Clinic, Toronto, ON, Canada

Sean Wharton

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  • , Esteban Jódar
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Contributions

W.T.G. contributed to acquisition, analysis and interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. R.L.B. contributed to analysis or interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. M.B. contributed to analysis and interpretation of data; drafting of the manuscript; and critical revision of manuscript for important intellectual content. S.B. contributed to concept and design; acquisition, analysis or interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. L.N.C. contributed to analysis and interpretation of data; critical revision of manuscript for important intellectual content; and statistical analysis. J.P.F. contributed to acquisition, analysis or interpretation of data; critical revision of the manuscript for important intellectual content; and supervision. E.J. contributed to acquisition, analysis or interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. K.K. contributed to analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis; and administrative, technical or material support. G.R. contributed to interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. T.A.W. contributed to interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. S.W. contributed to acquisition, analysis or interpretation of data; drafting of the manuscript; and critical revision of the manuscript for important intellectual content. Investigators were responsible for data collection, and the sponsor undertook site monitoring, data collation and analysis. All authors had full access to aggregated study data and to unaggregated data on request from the sponsor; participated in the data interpretation, presentation and manuscript drafting (assisted by a sponsor-funded medical writer); approved its submission, and vouched for data accuracy and fidelity to the protocol.

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Correspondence to W. Timothy Garvey .

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Competing interests.

W.T.G. reports a grant from Novo Nordisk; serving as site principal investigator for the current clinical trial, which was sponsored by his university during the conduct of the study; and receiving grants to serve as site principal investigator for other university-sponsored clinical trials funded by Eli Lilly & Company, Lexicon, Epitomee and Pfizer outside the submitted work. He also served as a compensated consultant on advisory committees for Alnylam, Amgen, Boehringer Ingelheim, Fractyl and Novo Nordisk, and a volunteer uncompensated consultant on advisory committees for Boehringer Ingelheim, Jazz Pharmaceuticals, Novo Nordisk and Pfizer. R.L.B. reports research grant support, on behalf of their institution, from Novo Nordisk and advisory/consultancy fees from Boehringer Ingelheim, Eli Lilly & Company, Gila Therapeutics Inc, GLW-01, International Medical Press, Novo Nordisk, Pfizer and ViiV. M.B. is an employee of Novo Nordisk A/S. S.B. served as site principal investigator for the clinical trial (he received no financial compensation, nor was there a financial relationship) and reports advisory/consulting fees and/or other support from Boehringer Ingelheim, Eli Lilly & Company, Guidotti Laboratories, Menarini Diagnostics, Novo Nordisk and Therascience Lignaform. L.N.C. is an employee of Novo Nordisk A/S. J.P.F. reports research support grants from Akero, AstraZeneca, Boehringer Ingelheim, BMS, 89bio, Eli Lilly & Company, Intercept, IONIS, Janssen, Madrigal, Metacrine, Merck, NorthSea Therapeutics, Novartis, Novo Nordisk, Oramed, Pfizer, Poxel and Sanofi; and advisory/consultancy fees from Akero, Altimmune, Axcella Health, Becton Dickenson, Boehringer Ingelheim, Carmot Therapeutics, Echosens, 89bio, Eli Lilly & Company, Gilead, Intercept, Metacrine, Merck, Novo Nordisk, Pfizer and Sanofi. E.J. reports grants from Amgen, AstraZeneca, Boehringer Ingelheim, FAES, Janssen, Eli Lilly & Company, MSD, Novo Nordisk, Pfizer, Sanofi, Shire and UCB; personal fees from Amgen, AstraZeneca, FAES, Helios-Fresenius, Italfármaco, Eli Lilly & Company, MSD, Mundipharma, Novo Nordisk, UCB and Viatris. K.K. is an employee of Novo Nordisk A/S. G.R. reports personal (advisory/consultancy and lecture) fees and nonfinancial support from iNova Pharmaceuticals, Nestle HealthScience and Novo Nordisk; personal (lecture) fees from Johnson & Johnson, Medtronic (formerly Covidien), Merck Sharpe & Dohme, ReShape Lifesciences (formerly Apollo-Endosurgery and Allergan Australia) and W.L. Gore Device Technologies. T.A.W. serves on advisory boards for Novo Nordisk and WW (formerly Weight Watchers), and has received grant support, on behalf of the University of Pennsylvania, from Novo Nordisk and from Epitomee Medical Ltd (the latter outside of the submitted work). S.W. reports research funding, advisory/consulting fees and/or other support from AstraZeneca, Bausch Health Inc., Boehringer Ingelheim, CIHR, Janssen, Eli Lilly & Company and Novo Nordisk.

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Extended data

Extended data fig. 1 trial design for step 5 clinical study., extended data fig. 2 body weight (kg) by week..

Observed mean body weight (kg) over time for participants in the full analysis set during the in-trial observation period (from randomization to last contact with trial site, regardless of treatment discontinuation or rescue intervention). Error bars are standard error of the mean. Numbers below the panels are the number of participants contributing to the mean.

Extended Data Fig. 3 Cumulative distribution plot of change from baseline to week 104 in body weight.

( a , b ) Cumulative distribution plot of observed percentage change from baseline over time in body weight for participants in the full analysis set during the in-trial observation period* (a) and on-treatment observation period † (b). *From randomization to last contact with trial site, regardless of treatment discontinuation or rescue intervention. † During treatment with trial product (any dose of trial medication administered within the previous 2 weeks (that is, any period of temporary treatment interruption with trial product was excluded)).

Extended Data Fig. 4 Comparison of change from baseline by week for selected cardiometabolic endpoints for semaglutide versus placebo.

( a - d ) Observed mean percentage change from baseline over time for participants in the full analysis set during the in-trial observation period in waist circumference (a), systolic blood pressure (b), diastolic blood pressure (c), and HbA 1c (d). Error bars are standard error of the mean; numbers below the panels are the number of participants contributing to the mean.

Extended Data Fig. 5 Shift from baseline to week 104 in glycemic status.

( a - d ) Observed data for participants in the full analysis set treated with semaglutide 2.4 mg (a, c) or placebo (b, d) during the in-trial period. As illustrated by the gray shading, the week 104 bars present results at this time point among the subgroups of participants with baseline prediabetes (a and b) or baseline normoglycemia (c and d). Glycemic category was determined by investigators on the basis of available information (for example, medical records, concomitant medication, and blood glucose variables) and in accordance with American Diabetes Association criteria, 30 which for prediabetes includes fasting plasma glucose levels of 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) or HbA 1c levels of 5.7–6.4% (39–47 mmol/L), and for type 2 diabetes includes fasting plasma glucose levels of ≥126 mg/dL (7.0 mmol/L) or HbA 1c levels ≥6.5% (48 mmol/L). *Number of participants in the full analysis set. † Number of participants with prediabetes (a and b) or normoglycemia (c and d) at baseline and evaluable data at week 104.

Extended Data Fig. 6 Comparison of body weight parameters for semaglutide versus placebo (trial product estimand).

( a ) Observed mean percentage change from baseline in body weight over time for participants in the full analysis set during the on-treatment observation period (error bars are standard error of the mean; numbers below the panels are the number of participants contributing to the mean) and estimated treatment difference for the percentage change from baseline to week 104 in body weight based on the trial product estimand. ( b ) Observed proportions of participants and odds ratio for achieving weight loss of at least 5% from baseline at week 104 in the full analysis set during the on-treatment observation period, based on the trial product estimand. *Estimated means in percent. A time point is considered as on treatment if any dose of trial product has been administered within the previous 14 days. The trial product estimand assesses treatment effect assuming all participants adhered to treatment and did not receive rescue intervention. CI, confidence interval; ETD, estimated treatment difference.

Extended Data Fig. 7 Prevalence and duration of gastrointestinal events by severity.

( a - d ) The proportion of participants receiving semaglutide or placebo who reported nausea (a), diarrhea (b), constipation (c), or vomiting (d) events classed as mild, moderate, or severe over the course of the treatment period. Data are from the on-treatment observation period (during treatment with trial product [any dose of trial medication administered within the previous 49 days (that is, any period of temporary treatment interruption with trial product was excluded)). Adverse events were classified by severity as mild (easily tolerated, causing minimal discomfort, and not interfering with everyday activities), moderate (causes sufficient discomfort and interferes with normal everyday activities), or severe (prevents normal everyday activities).

Supplementary information

Supplementary information.

List of investigators in the STEP 5 trial and Supplementary Tables 1–4.

Reporting Summary

Supplementary data 1.

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Garvey, W.T., Batterham, R.L., Bhatta, M. et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med 28 , 2083–2091 (2022). https://doi.org/10.1038/s41591-022-02026-4

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Once-Weekly Semaglutide in Adults with Overweight or Obesity

Collaborators.

  • STEP 1 Study Group : Marianela Aguirre Ackermann ,  Cecilia Luquez ,  Marcos Mayer ,  Carla Musso ,  Susana Salzberg ,  Ides Colin ,  Ann Mertens ,  André Scheen ,  Jean-Paul Thissen ,  Luc Van Gaal ,  Zhivka Asyova ,  Anna-Maria Borissova ,  Nickolay Botushanov ,  Ivona Daskalova ,  Zdravko Kamenov ,  Adam Blackman ,  Martin D'Amours ,  Isabelle Labonte ,  Stephanie Li ,  Edmonton Edmonton ,  Derek Lowe ,  Sean Wharton ,  Sanaz Zarinehbaf-Asadi ,  Bjørn Richelsen ,  Kirsi Pietiläinen ,  Markku Savolainen ,  Sebastien Czernichow ,  Emmanuel Disse ,  Pierre Benite ,  Kamel Mohammedi ,  Arnaud Monier ,  Christine Poitou-Bernert ,  Pierre Serusclat ,  Jean-Francois Thuan ,  Christel Contzen ,  Moritz Mauro Erlinger ,  Michael Esser ,  Thomas Linn ,  Jörg Lüdemann ,  Karsten Milek ,  Nicoletta Nalazek ,  Andrea Rinke ,  Joachim Sauter ,  Thomas Schürholz ,  Alexander Segner ,  Liana Vismane ,  Ulrich Wendisch ,  Syamasis Bandyopadhyay ,  Dipti Chand ,  Piyush Desai ,  Vaishali Deshmukh ,  Yashdeep Gupta ,  P K Jabbar ,  Dinesh Jain ,  K Neelaveni ,  Shriraam Mahadevan ,  Rajesh Rajput ,  Sudhakar Reddy ,  Kongara Srikanth ,  A Unnikrishnan ,  Satoshi Inoue ,  Arihiro Kiyosue ,  Osamu Matsuoka ,  Hiraku Ono ,  Masamichi Yamada ,  Diego Espinoza Peralta ,  Silvia Jimenez-Ramos ,  Carlos Medina Pech ,  Pawel Bogdanski ,  Malgorzata Jozefowska ,  Agata Leksycka ,  Jaroslaw Ogonowski ,  Diana Alpenidze ,  Olga Ershova ,  Marina Kharakhulakh ,  Vadim Klimontov ,  Ludmila Ruyatkina ,  Marina Sergeeva-Kondrachenko ,  Ekaterina Troshina ,  Elena Zhdanova ,  Kuo-Chin Huang ,  Rachel Batterham ,  Matt Capehorn ,  Rhodri King ,  Michael Lean ,  Barbara McGowan ,  Khin Swe Myint ,  Adrian Park ,  Harpal Randeva ,  Georgina Russell ,  John Wilding ,  Hanid Audish ,  Darlene Bartilucci ,  Harold Bays ,  Ronald Brazg ,  Robert Broker ,  Kevin Cannon ,  Tira Chaicha-Brom ,  Matthew Davis ,  H Jackson Downey ,  Stephen Fehnel ,  Almena Free ,  Amina Haggag ,  Mitzie Hewitt ,  Priscilla Hollander ,  Misal Khan ,  Karen Laufer ,  Robert McNeill ,  John Nardandrea Jr ,  Lisa Neff ,  Kevin Niswender ,  Patrick O'Neil ,  John Pullman ,  Marina Raikhel ,  Scott Redrick ,  John Reed 3rd ,  Michele Reynolds ,  Luis Rivera-Colon ,  Julio Rosenstock ,  Erich Schramm ,  John Scott ,  Stephanie Shaw ,  Vijay Shivaswamy ,  Timothy Smith ,  Joseph Soufer ,  Stephen Straubing ,  Danny Sugimoto ,  Phillip Toth ,  Ralph Wade ,  Holly Wyatt ,  Lan Wynne

Affiliation

  • 1 From the Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool (J.P.H.W.), University College London Centre for Obesity Research, Division of Medicine, University College London (R.L.B.), the National Institute of Health Research, UCLH Biomedical Research Centre (R.L.B.), the Centre for Weight Management and Metabolic Surgery, University College London Hospital (R.L.B.), and the Department of Diabetes and Endocrinology, Guy's and St. Thomas' NHS Foundation Trust (B.M.M.), London, and the Diabetes Research Centre, University of Leicester (M.D.) and the NIHR Leicester Biomedical Research Centre (M.D.), Leicester - all in the United Kingdom; Novo Nordisk, Søborg, Denmark (S.C., M.T.D.T., N.Z.); the Department of Endocrinology, Diabetology, and Metabolism, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium (L.F.V.G.); the Departments of Internal Medicine/Endocrinology and Population and Data Sciences, University of Texas Southwestern Medical Center (I.L.), and the Dallas Diabetes Research Center at Medical City (J.R.) - both in Dallas; the Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia (T.A.W.); York University, McMaster University and Wharton Weight Management Clinic, Toronto (S.W.); the Department of Endocrinology, Hematology, and Gerontology, Graduate School of Medicine, Chiba University and Department of Diabetes, Metabolism, and Endocrinology, Chiba University Hospital, Chiba, Japan (K.Y.); and the Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago (R.F.K.).
  • PMID: 33567185
  • DOI: 10.1056/NEJMoa2032183

Background: Obesity is a global health challenge with few pharmacologic options. Whether adults with obesity can achieve weight loss with once-weekly semaglutide at a dose of 2.4 mg as an adjunct to lifestyle intervention has not been confirmed.

Methods: In this double-blind trial, we enrolled 1961 adults with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or greater (≥27 in persons with ≥1 weight-related coexisting condition), who did not have diabetes, and randomly assigned them, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle intervention. The coprimary end points were the percentage change in body weight and weight reduction of at least 5%. The primary estimand (a precise description of the treatment effect reflecting the objective of the clinical trial) assessed effects regardless of treatment discontinuation or rescue interventions.

Results: The mean change in body weight from baseline to week 68 was -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points (95% confidence interval [CI], -13.4 to -11.5; P<0.001). More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1%] vs. 69 [12.0%]), and 15% or more (612 [50.5%] vs. 28 [4.9%]) at week 68 (P<0.001 for all three comparisons of odds). The change in body weight from baseline to week 68 was -15.3 kg in the semaglutide group as compared with -2.6 kg in the placebo group (estimated treatment difference, -12.7 kg; 95% CI, -13.7 to -11.7). Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo. Nausea and diarrhea were the most common adverse events with semaglutide; they were typically transient and mild-to-moderate in severity and subsided with time. More participants in the semaglutide group than in the placebo group discontinued treatment owing to gastrointestinal events (59 [4.5%] vs. 5 [0.8%]).

Conclusions: In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight. (Funded by Novo Nordisk; STEP 1 ClinicalTrials.gov number, NCT03548935 ).

Copyright © 2021 Massachusetts Medical Society.

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As Semaglutide’s Popularity Soars, Rare but Serious Adverse Effects Are Emerging

  • Medical News & Perspectives As Ozempic’s Popularity Soars, Here’s What to Know About Semaglutide and Weight Loss Melissa Suran, PhD, MSJ JAMA
  • Research Letter GLP-1 Agonists and Gastrointestinal Adverse Events Mohit Sodhi, MSc; Ramin Rezaeianzadeh, BSc; Abbas Kezouh, PhD; Mahyar Etminan, PharmD, MSc JAMA
  • Review Review of Obesity Management in Adults Arielle Elmaleh-Sachs, MD, MS; Jessica L. Schwartz, MD, MHS; Carolyn T. Bramante, MD, MPH; Jacinda M. Nicklas, MD, MPH; Kimberly A. Gudzune, MD, MPH; Melanie Jay, MD, MS JAMA
  • Medical News & Perspectives What to Know About Zepbound, the Newest Antiobesity Drug Jennifer Abbasi JAMA
  • Medical News in Brief Semaglutide Linked With Lower Risk of Suicidal Thoughts Emily Harris JAMA

In June of 2021, the US Food and Drug Administration (FDA) approved the drug semaglutide for chronic weight management under the brand name Wegovy, ushering in a new era of obesity treatment. Since then, demand for Wegovy and the type 2 diabetes therapy Ozempic—which contains the same drug and has commonly been prescribed off-label for weight loss—have outpaced production, causing ongoing shortages of these injections. And on November 8 of this year, the FDA approved tirzepatide injections for weight management under the brand name Zepbound. The much-anticipated new antiobesity drug, which has been sold as Mounjaro for diabetes since last year , includes 2 active ingredients, one of them in the same drug class as semaglutide.

Read More About

Ruder K. As Semaglutide’s Popularity Soars, Rare but Serious Adverse Effects Are Emerging. JAMA. 2023;330(22):2140–2142. doi:10.1001/jama.2023.16620

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Beyond Ozempic: Trials Hold Promise of Highly Effective Obesity Drugs

Semaglutide, also known by its brand names Ozempic and Wegovy, marks a new era in anti-obesity therapeutics. The unprecedented drug offers a safe and effective option for patients that addresses the root of obesity. But this is only the beginning. More novel medications are coming down the pipeline that will further revolutionize obesity medicine, with much of the cutting-edge work being led at Yale with three simultaneous publications in the New England Journal of Medicine and Lancet in June.

We are truly transforming the way we can care for our patients with obesity now and going forward with these emerging new pharmacotherapeutics. Ania Jastreboff, MD, PhD

The United States and countries around the world are facing a skyrocketing obesity epidemic, but until recently, clinicians had few effective therapies to offer patients. Now, numerous clinical trials are exploring new pharmacotherapies that target the mechanisms underlying the disease. Among the drugs researchers are evaluating are retatrutide and tirzepatide [Mounjaro] (the latter, FDA-approved for type 2 diabetes), which are weekly injectable medications that clinical trials are showing to be highly effective in treating obesity and type 2 diabetes. While not yet FDA-approved for chronic weight management, they show promise to eventually outshine the current drugs dominating the market.

“It’s an exciting time to lead research in the rapidly evolving landscape of anti-obesity pharmacotherapeutics,” says Ania Jastreboff, MD, PhD , associate professor of medicine (endocrinology) and of pediatrics (pediatric endocrinology), director of the Yale Obesity Research Center (Y-Weight) and co-director of the Yale Center for Weight Management , and a leader in studying this new class of therapeutics. “We are truly transforming the way we can care for our patients with obesity now and going forward with these emerging new pharmacotherapeutics.”

Obesity is a chronic neurometabolic disease that impacts nearly half of Americans. And by 2035, researchers estimate that the disease will affect nearly a quarter of the world’s population. Because obesity is associated with as many as 200 weight-related diseases, developing highly effective and safe interventions that address the underlying causes of disease is critical.

The body has evolved a beautiful, intricate system in which hormones send signals to the brain about the body’s energy state. However, drivers of obesity—including highly processed foods, increased stress, lack of physical activity, and decreased sleep—can pathologically alter this system and make it extremely difficult to lose weight. The goal of the new nutrient-stimulated hormone-based medications, such as semaglutide and tirzepatide, that Jastreboff and colleagues are evaluating is to safely and effectively treat obesity by reregulating this system.

Retatrutide Is Highly Effective in Treating Obesity

Retatrutide is a novel triple-hormone-receptor agonist that targets three nutrient-stimulated hormone receptors—glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide 1 (GLP-1), and glucagon (GCG). The recent phase 2 clinical trial led by Jastreboff and published in the New England Journal of Medicine on June 26 evaluated the efficacy and safety of this molecule. The trial enrolled 338 patients who were randomized to receive a weekly injection of retatrutide or a placebo for 48 weeks. Of those in the experimental group, participants received varying dosages ranging from 1 mg to 12 mg.

The results were substantial. Participants who received the highest dose of retatrutide on average lost nearly a quarter of their baseline body weight (24.2%) over the 11 months of the trial—on average, 58 pounds. Furthermore, all participants receiving an 8 mg or 12 mg dose met their weight reduction target of greater than or equal to 5% of body weight. This number matters because the U.S. Food and Drug Administration (FDA) has deemed the 5% threshold to be clinically significant—in other words, this degree of weight reduction is linked to metabolic and other health benefits.

The trial also explored how baseline characteristics of patients may predict how well they will respond to the medication. The team studied baseline body mass index (BMI) and sex. They found that participants who had a baseline BMI greater than or equal to 35 lost more weight than participants with a lower BMI. “We found that individuals with more severe obesity lost a greater percent of their body weight than those with less severe obesity,” says Jastreboff.

The team also found that on average, women lost a greater percent of their body weight than men. “These findings need to be explored further to understand why this is occurring, to elucidate the underlying mechanisms,” says Jastreboff.

In terms of safety and tolerability, the study identified the most common side effects as gastrointestinal. They were mild to moderate in severity and occurred mostly during dose escalation.

Overall, Jastreboff says the results support moving retatrutide to phase 3 trials, which are the clinical trials required by the FDA to determine safety and efficacy and regularly enable decisions about drug approvals.

Retatrutide Is Effective for Type 2 Diabetes Management

Jastreboff also co-authored a clinical trial published in the Lancet on June 26 studying retatrutide for type 2 diabetes management. The trial was conducted over 36 weeks and included 281 participants. One way researchers can evaluate a patient’s glycemic control is through a hemoglobin A1C (HbA1C) test, which provides an average of the individual’s blood sugar levels over three months.

After 36 weeks, the average HbA1C reduction across patients receiving the highest dose of the drug was 2.16%. Furthermore, patients receiving the highest dose saw an average weight reduction of 16.9%.

On average, participants with type 2 diabetes in this trial lost less weight on retatrutide than participants in the obesity clinical trial. There are several reasons for this, Jastreboff explains. First, prior research has shown that individuals with type 2 diabetes generally lose less weight than those with obesity alone. Furthermore, the length of the trial was shorter than the obesity trial. But for both of the trials, the weight reduction curve had yet to plateau. “Participants were still losing weight at the time the study drug was stopped,” says Jastreboff. “Had the study drug been continued, we would anticipate that the participants would have continued losing weight in both trials.”

Tirzepatide Trials Show Promise for Obesity and Type 2 Diabetes Management

In 2022, Jastreboff was lead author of a phase 3 clinical trial published in the New England Journal of Medicine called SURMOUNT-1, a 72 week-long study that included over 2,000 participants with obesity investigating the efficacy and safety of tirzepatide, a novel GIP/GLP-1 receptor agonist. The team found that individuals treated with 15 mg of tirzepatide lost 22.5% of their body weight.

A year later, Jastreboff co-authored the SURMOUNT-2 phase 3 trial, which included 938 patients with type 2 diabetes and was published in the Lancet on June 26 of this year. In this randomized study, participants either received 15 mg of tirzepatide, 10 mg of tirzepatide, or a placebo. Over 72 weeks, the researchers saw an average weight loss of 15.7% and an average HbA1C reduction of about 2%. Approximately half of the participants lost more than 15% of their total body weight.

Looking to the Future of Obesity Management

Retatrutide is now moving into phase 3 clinical trials. Tirzepatide is further along; with the completion of the phase 3 SURMOUNT-2 trial, it is now undergoing FDA regulatory review for a chronic weight management (obesity) indication.

Retatrutide and tirzepatide are just two of the many agents in development for the treatment of obesity. Researchers are investigating numerous combinations of nutrient-stimulated hormone-based injectable medications. They are also testing oral formulations of this class of drugs, including higher doses of oral semaglutide, an oral formulation of the peptide which recently completed phase 3 obesity trials, as well as small molecule (non-peptide) GLP-1 receptor agonists such as orforglipron, which recently completed phase 2 and is moving into phase 3 trials. Oral formulations of these medications may provide options for patients who prefer pills to injections, which could improve accessibility.

Because obesity is a complex disease with different pathophysiological mechanisms, having numerous tools in the arsenal will be essential for overcoming the epidemic. “For various chronic diseases, such as type 2 diabetes, we have many different classes of medications, and several medications within each class,” says Jastreboff. “That’s what we need for our patients with obesity. We need a diverse set of tools to enable us to individualize and optimize obesity care and provide our patients with treatment options which best meet their health goals.”

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Living Better

Less snacking, more satisfaction: some foods boost levels of an ozempic-like hormone.

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Michaeleen Doucleff

new research on ozempic

A fiber found in barley, called beta-glucan, may improve insulin sensitivity, lower blood pressure and increase satiation between meals, research shows. LauriPatterson/Getty Images hide caption

A fiber found in barley, called beta-glucan, may improve insulin sensitivity, lower blood pressure and increase satiation between meals, research shows.

For several months now, I've been studying how the new medications, Ozempic and Wegovy, cause dramatic weight loss.

Both medications contain a compound, semaglutide, that squelches hunger like a fly swatter smashes a mosquito. People who take the medication say they no longer have constant cravings for food, so they eat less frequently. The drug seems to quiet what some people call "food noise," the constant internal chatter telling them to eat.

While reading study after study about Wevgovy and Ozempic, I learned that the drug mimics a hormone that our bodies naturally make when we're eating food. It's called GLP-1. This made me wonder: Could we increase levels of this hormone by changing our diet?

Turns out, the answer is yes – you can increase your body's production of GLP-1 with your diet, says Frank Duca , who studies metabolic diseases at the University of Arizona . One of the key foods that triggers its release is a food most Americans struggle to eat enough of, even though it comes with a cornucopia of health benefits. Yup, I'm talking about fiber.

" Whenever my family finds out that I'm studying obesity or diabetes, they say, 'Oh, what's the wonder drug? What do I need to take? What do I need to do?'" Duca explains. "And I say, 'Eat more fiber.' "

But here's the hitch. Not all fiber works the same way. Duca and other researchers are beginning to show that particular types of fibers are more potent at triggering GLP-1 release and at regulating hunger than others. "We're seeing now that companies are adding fiber to foods, but a lot of the time, they don't add the kind of fiber that's super beneficial for you," Duca says.

How GLP-1 helps flip hunger into satisfaction

To understand why fiber is so important for producing GLP-1, let's look at what happens when you don't eat much fiber. Let's say you wake up in the morning feeling hungry and you eat two slices of white bread and a fried egg. As the digested food moves into the small intestine, many of the nutrients, such as the carbohydrates, fats and amino acids, trigger an avalanche of activity in your blood and brain.

"The food activates cells in your intestine, which then release a ton of hormones," says Sinju Sundaresan , who's a gut physiologist at Midwestern University. About 20 of these hormones, including GLP-1, are known as satiation hormones.

"They tell your body to start absorption, and to suppress your hunger signals," Sundaresan says. So you slow down eating and eventually stop because you feel satisfied.

At this point, GLP-1 kicks into action. It stimulates the release of insulin and slows down how quickly the bread and egg moves from your stomach into the intestine. So you don't use up the fuel all at once, says Gary Schwartz , who studies the neuroscience of eating and appetite at Albert Einstein College of Medicine.

GLP-1 also likely activates neural circuitry inside the brain by turning on nerves inside the lining of your gut. "These neurons collect information from the gut, and then signal all the way to the brain stem, where you find another signaling pathway for GLP-1," Schwartz explains.

But GLP-1's actions are extremely fast. "Once the hormone hits the blood, it begins to be degraded," says integrated physiologist Darleen Sandoval , at the University of Colorado, who has studied GLP-1 for more than a decade. "By the time GLP-1 gets to the heart and the rest of the circulation, there's very little of it left," she says.

And so an hour or two after eating this no-fiber breakfast, GLP-1 levels in your blood plummet. And when lunch rolls around, you're hungry again.

This is where GLP-1 differs substantially from semaglutide, the active ingredient in weight-loss drugs. GLP-1 sticks around in the blood for only a few minutes, but semaglutide persists for days. And this stability allows the drug to go into the brain, where it squelches appetite and cravings directly, says Sandoval. That's why people on these drugs lose so much weight. "In mice or rats, we can give naturally occurring GLP-1 directly into the animals' brains, and it stops them from eating," Sandoval says.

But, back to our breakfast scenarios: What if, instead of eating white bread, you had two slices of high-fiber rye bread, with about 8 to 10 grams of fiber in them? Turns out, adding that hefty portion of fiber adds another opportunity for your intestine to release GLP-1, many hours after the meal.

Satiation hormones last longer after eating fiber

Our bodies don't have the capacity to break down fiber. So it moves through our small intestines largely unchanged, and eventually – approximately 4 to 10 hours after a meal – reaches our colons.

Here, inside the large intestine, the fiber meets a whole crew of microbes that can digest the fiber. Bacteria in your large intestine can break down certain dietary fibers into smaller molecules. And these smaller molecules can trigger the release of not only GLP-1, but also another key hormone that decreases your appetite, called PYY (peptide YY). These smaller molecules also can suppress appetite on their own, and have been linked to lower body weight and better glucose regulation.

Since this extra boost of GLP-1 and PYY occurs hours after you eat, it can tamp down cravings between meals and even the overall desire to eat the next meal. "PPY regulates satiety – that is how long you wait between meals," says the University of Arizona's Frank Duca . "The release of PYY, in addition to the GLP-1, can increase the length of time between meals," he says.

We've heard we need more fiber in our diets. Here are 8 easy tips for getting there

We've heard we need more fiber in our diets. Here are 8 easy tips for getting there

These hormones may even influence how much you eat at the next meal. "This is what's called a second meal effect ," says Edward Deehan , a nutritional microbiologist at the University of Nebraska-Lincoln. "If you eat a lot of fiber at one meal, by the time it's in your colon, it's around the time of your next meal. So you may have improved insulin responses and improved satiety or a feeling of fullness," Deehan says.

But, not all fiber is equal: To get this extra boost of satiation hormones, you need to eat fiber that bacteria can digest. These fibers are called fermentable because bacteria literally ferment them, in a similar way that yeast ferments barley into beer.

Scientists, such as Duca, have just started trying to figure out which fermentable fibers may be best at suppressing appetite and inducing weight-loss. "So the agricultural community in the U.S. could prioritize the growing of grains with these fibers," he explains.

In one preliminary study with mice, Duca and his colleagues found that a fiber in barley, called beta-glucan, induced the most weight loss in obese animals. "At face value and, at least in our settings, it was only beta-glucan that was effective, " he says.

How To Add Barley To Your Diet

Cooking barley is super easy. Some recipes call for soaking the grain before boiling. But it's not necessary. Simply add one cup of barley and three cups of water to a pot.

For pearled barley, continue boiling for about 30 minutes. For hulled barley, boil for about 40 minutes. Strain the water and you're ready!

You can throw barley into soups or on salads and boiled barley is a great fiber-rich substitute for white rice. You can also buy barley flour and use it for baking breads, muffins and pancakes.

Beta-glucan is also found in oats and rye. And indeed, studies with people have found that beta-glucan fiber may improve insulin sensitivity, lower blood pressure and increase satiation between meals.

Other fermentable fibers include dextrin in wheat, oligosaccharides in beans, peas and lentils, and pectin in apples, pears and green bananas.

If your diet currently doesn't include much fiber, Duca says, don't worry too much about which fiber you start adding. "Just being aware of how much fiber you're eating and increasing it, that's a huge step to improving your health," he says. "Then once you get into the habit of eating more fiber, you can be more specific about adding more beta glucan and barley."

But beware of processed foods that claim to have fiber added to them, Duca says. "Companies are hearing that they need to increase the fiber in their foods, but then a lot of times, they're adding fiber that isn't super beneficial for you," he says. "It's the type of fiber that just passes right through you, without triggering the release of any hormones."

Prebiotic sodas promise to boost your gut health. Here's what to eat instead

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Prebiotic sodas promise to boost your gut health. here's what to eat instead.

This story was edited by Jane Greenhalgh

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The surprising mental health and brain benefits of weight-loss drugs

Drugs like Ozempic and Wegovy have unexpected effects on the brain, opening up potential new ways to treat depression, anxiety, addiction and Alzheimer’s

By Simar Bajaj

12 June 2024

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Kathy Schwartz was 10 years free from alcohol, cigarettes and opiates but every day it was painful to control her cravings. “They were always in the background,” she says. In June last year, however, this noise fell silent.

Prescribed the weight-loss drug semaglutide, she not only lost nearly 30 kilograms over 10 months, but also her desire to reach for a drink or take some pills. “I do not crave, which I didn’t think would be a side effect,” says Schwartz. Remarkably, the depression and anxiety that would previously come over her in waves also calmed down.

Unravelling the secrets of the vagus nerve will revolutionise medicine

Unravelling the secrets of the vagus nerve will revolutionise medicine

Vagus nerve stimulation is used to treat conditions ranging from inflammation to migraine. Mapping the nerve's complex structure of more than 160,000 fibres could usher in a new era of precision treatments

Schwartz isn’t alone in this experience. New research is revealing the surprising brain and mental health benefits of semaglutide drugs such as Ozempic and Wegovy, and other related diabetes and weight-loss drugs that mimic a gut hormone released after eating.

It is early days, but there are hints that these drugs could be repurposed to treat depression, anxiety, addiction and even certain eating disorders – as well as neurological conditions such as Parkinson’s disease and Alzheimer’s. What’s more, it seems that these effects aren’t just mediated via weight loss, but through direct action on the brain.

The story of drugs like Ozempic starts back in the 1970s and 1980s when researchers discovered that a gut hormone called glucagon-like peptide-1 (GLP-1) could stimulate insulin production when injected into rodents in the…

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Your Body Has Its Own Built-In Ozempic

Popular weight-loss and diabetes drugs, such as Ozempic and Wegovy, target metabolic pathways that gut microbes and food molecules already play a key role in regulating

By Christopher Damman & The Conversation US

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The following essay is reprinted with permission from The Conversation , an online publication covering the latest research.

Wegovy, Ozempic and Mounjaro  are weight loss and diabetes drugs that have made quite a splash in  health news . They target regulatory pathways involved in both  obesity and diabetes  and are widely considered breakthroughs for weight loss and blood sugar control.

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But do these drugs point toward a root cause of metabolic disease?  What inspired  their development in the first place?

It turns out your body produces natural versions of these drugs – also known as  incretin hormones  – in your gut. It may not be surprising that  nutrients in food  help regulate these hormones. But it may intrigue you to know that the trillions of  microbes in your gut  are key for orchestrating this process.

I am a gastroenterologist  at the University of Washington who studies how  food and your gut microbiome  affect health and disease. Here’s an inside-out perspective on the role natural gut hormones and healthy food play in metabolism and weight loss.

A broken gut

Specialized bacteria in your lower gut take the components of food you can’t digest like  fiber  and  polyphenols  – the elements of plants that are removed in many processed foods – and transforms them into molecules that stimulate hormones to control your  appetite and metabolism . These include GLP-1, a natural version of Wegovy and Ozempic.

GLP-1  and other hormones like  PYY  help regulate blood sugar through the pancreas. They also tell your brain that you’ve had enough to eat and your stomach and intestines to slow the movement of food along the digestive tract to allow for digestion. This system even has a name: the  colonic brake .

Prior to modern processed foods, metabolic regulatory pathways were under the direction of a  diverse healthy gut microbiome  that used these hormones to naturally regulate your metabolism and appetite. However,  food processing , aimed at improving shelf stability and enhancing taste, removes the bioactive molecules like  fiber  and  polyphenols  that help regulate this system.

Removal of these key food components and the resulting decrease in gut microbiome diversity may be an important factor contributing to the rise in  obesity and diabetes .

A short track to metabolic health

Wegovy and Ozempic reinvigorate the colonic brake downstream of food and microbes with molecules similar to GLP-1. Researchers have demonstrated their effectiveness at  weight loss and blood sugar control .

Mounjaro has gone a step further and combined GLP-1 with a second hormone analogue derived from the upper gut called GIP, and studies are showing this combination therapy to be even more effective at  promoting weight loss  than GLP-1-only therapies like Wegovy and Ozempic.

These drugs complement other measures like  gastric bypass surgery  that are used in the most extreme cases of metabolic disease. These surgeries may in part  work much like Wegovy and Ozempic  by bypassing digestion in segments of the gastrointestinal tract and bathing your  gut microbes  in less digested food. This awakens the microbes to stimulate your gut cells to produce  GLP-1  and  PYY , effectively regulating appetite and metabolism.

Many patients have seen significant improvements to not only their weight and blood glucose but also reductions in important cardiovascular outcomes like  strokes and heart attacks .  Medical guidelines  support the use of new incretin-based medications like Wegovy, Ozempic and Mounjaro to manage the interrelated metabolic conditions of diabetes, obesity and cardiovascular disease.

Considering the effects incretin-based medications have on the brain and cravings, medical researchers are also evaluating their potential to treat nonmetabolic conditions like  alcohol abuse ,  drug addiction  and  depression .

A near-magic bullet – for the right folks

Despite the success and prospect of these drugs to help populations that may benefit most from them, current  prescribing practices  have raised some questions. Should people who are only a little overweight use these drugs? What are the risks of prescribing these drugs to  children and adolescents  for lifelong weight management?

While incretin-based therapies seem close to magic bullets, they are not without gastrointestinal side effects like  nausea, vomiting, diarrhea and constipation . These symptoms are related to how the drugs work to slow the gastrointestinal tract. Other more severe, but rare, side effects include  pancreatitis and irreversible gastroparesis , or inflammation of the pancreas and stomach paralysis.

These drugs can also lead to a  loss of healthy lean muscle mass  in addition to fat, particularly in the absence of exercise. Significant  weight gain  after stopping the drugs raises further questions about  long-term effects  and whether it’s possible to transition back to using only lifestyle measures to manage weight.

All roads lead to lifestyle

Despite our greatest aspirations for quick fixes, it’s very possible that a  healthy lifestyle  remains the most important way to manage metabolic disease and overall health. This includes regular exercise, stress management, sleep, getting outdoors and a balanced diet.

For the majority of the population who don’t yet have obesity or diabetes, restarting the gut’s built-in appetite and metabolism control by reintroducing whole foods and awaking the gut microbiome may be the best approach to promote healthy metabolism.

Adding minimally processed foods back to your diet, and specifically those replete in  fiber  and  polyphenols  like flavonoids and carotenoids, can play an important and complementary role to help address the epidemic of obesity and metabolic disease at one of its deepest roots.

This article was originally published on The Conversation . Read the original article .

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How Americans View Weight-Loss Drugs and Their Potential Impact on Obesity in the U.S.

Many view these drugs as good options for people with weight-related health conditions; doubts about national impact on obesity, table of contents.

  • Views of weight-loss drugs
  • Impact of weight-loss drugs on obesity in America
  • How Americans think about weight and weight loss
  • What factors impact a person’s weight?
  • Acknowledgments
  • The American Trends Panel survey methodology
  • Appendix: Detailed chart and tables

new research on ozempic

Pew Research Center conducted this study to understand Americans’ views of drugs being used for weight loss. For this analysis, we surveyed 10,133 U.S. adults from Feb. 7 to 11, 2024.

Everyone who took part in the survey is a member of the Center’s American Trends Panel (ATP), an online survey panel that is recruited through national, random sampling of residential addresses. This way, nearly all U.S. adults have a chance of selection. The survey is weighted to be representative of the U.S. adult population by gender, race, ethnicity, partisan affiliation, education and other categories. Read more about the ATP’s methodology .

Here are the questions used for this report , along with responses, and its methodology .

A new Pew Research Center survey examines Americans’ attitudes about a new class of drugs being used for weight loss, including Ozempic and Wegovy.

In this report, we cover views of:

  • The use of weight-loss drugs
  • The impact of weight-loss drugs on obesity in America
  • The factors that impact a person’s weight, including the role of willpower

About three-quarters of Americans say they have heard a lot or a little about Ozempic, Wegovy and other similar drugs that are being used for weight loss. Among those familiar with these drugs, 53% think they are good options to lose weight for people with obesity or a weight-related health condition, while just 19% think they are not good options and 28% say they’re not sure.

Bar chart showing that many Americans view Ozempic, Wegovy and other similar drugs as good options for weight loss for people with obesity; far fewer support their use by people without a weight-related health condition.

By contrast, just 12% of those familiar with these drugs say they are good options for people who want to lose weight but do not have a weight-related health condition. A far larger share (62%) say these drugs are not good options for people without a weight-related health condition, while 26% aren’t sure.

Ozempic and Wegovy belong to a class of drugs called GLP-1 agonists that manage blood sugar levels and suppress appetite. Ozempic is approved by the Food and Drug Administration for treating diabetes, while Wegovy is approved for people with obesity or excess weight who also have a weight-related health condition. Mounjaro and Zepbound are other similar drugs. Mounjaro is for treating diabetes, while Zepbound is for people with obesity. 1

Demand for Ozempic and Wegovy has led to supply shortages , raising concerns about off-label use and impacting people who rely on these drugs to manage their health conditions. 2

Some experts have heralded drugs like Ozempic as a breakthrough for treating obesity in America and a catalyst for changing the way excess weight conditions are understood. 3

Chart shows Modest expectations for the impact Ozempic and other similar drugs will have on obesity in America

For now, the public has modest expectations for the impact drugs like Ozempic and Wegovy will have on obesity in the United States. Only 16% of those familiar with these drugs think they will do a great deal or quite a bit to reduce obesity, while 35% think they will do some and 33% expect they will do not much or nothing at all to reduce obesity in the U.S. (15% say they’re not sure).

About four-in-ten U.S. adults have obesity, according to the Centers for Disease Control and Prevention , and there’s been a significant increase in the share of Americans with this disease over the past two decades. Obesity is linked to a number of conditions that can lead to premature death, including heart disease and type 2 diabetes. It also accounts for billions of dollars in health care costs each year.

By and large, views on the use and impact of weight-loss drugs are similar across most major demographic groups. For instance, comparable shares of women (56%) and men (51%) who are familiar with these drugs think they are good options for weight loss for people with obesity or a weight-related health condition. And men and women are also similar in their expectations about the impact these drugs will have on obesity in the U.S. Go to the Appendix for more details .

One modest difference in views: Those who have heard a lot about these drugs are somewhat more optimistic than those who have heard a little to say they will reduce obesity in the U.S. a great deal or quite a bit (27% vs. 11%).

The boom in popularity of Ozempic and other similar drugs has become part of a broader societal discusion about weight and the factors that shape it, including behavior, environment and genetics .

Bar chart showing that 65% of Americans say willpower alone is not enough for most people to lose weight and keep it off. This view is widely held across most demographic groups

On balance, Americans do not believe willpower alone is enough to lose weight and keep it off. About two-thirds (65%) say willpower alone is usually not enough for people who are trying to lose weight and keep it off. By contrast, 34% think that willpower is usually enough for most people who are trying to lose weight.

The view that losing weight is not only a matter of willpower is widely held across most demographic groups. There are, however, some differences by demographic characteristics:

  • Gender: Women are more likely than men to say willpower alone is not enough for most people (71% vs. 59%).
  • Race and ethnicity: Large majorities of White and Black adults say willpower alone is not enough to lose weight and keep it off (68% and 70%, respectively). Smaller majorities of Hispanic and English-speaking Asian adults say the same (55% and 54%).
  • Age: Larger shares of older than younger adults believe that willpower alone is not enough for most people to lose weight (though this remains the predominant view across all age groups).

Bar chart showing Americans’ views on weight loss and willpower by respondents’ description of their own weight. Majorities of adults across all perceived weight types say losing weight and keeping it off involves more than just willpower alone.

The survey also includes a question on respondents’ self-reported perception of their own weight that is used in CDC surveys .

Notably, majorities of adults across all perceived weight types say losing weight and keeping it off involves more than just willpower alone. Among those who describe their weight as very or slightly overweight, 71% say willpower alone is usually not enough for people who are trying to lose weight. Majorities of those who describe their weight as about right (56%) or very or slightly underweight (61%) also take this view, though by somewhat smaller margins.

Asked about the impact of different factors on a person’s weight, Americans rank diet at the top of the list: A large majority says diet affects a person’s weight a great deal (57%) or quite a bit (29%). Exercise habits rank second, with 43% saying this impacts a person’s weight a great deal and 36% saying it has quite a bit of impact.

Bar chart showing that a large majority of Americans say diet affects a person’s weight a great deal (57%) or quite a bit (29%). Exercise habits rank second, with 43% saying this impacts a person’s weight a great deal and 36% saying it has quite a bit of impact. Three-quarters say stress and anxiety has at least quite a bit of impact on a person’s weight. A majority says genetics influence weight at least quite a bit, while about half say the same about grocery store access.

Three-quarters of Americans say stress and anxiety has at least quite a bit of impact on a person’s weight, including 35% who say it has a great deal of impact.

A majority also says genetics influence a person’s weight at least quite a bit, though the share saying genetics has a great deal of impact (22%) is 13 percentage points lower than the share who say the same about stress and anxiety.

Roughly half say access to grocery stores affects a person’s weight at least quite a bit, including 20% who say it has a great deal of impact. Access to grocery stores and things like safe, convenient places to exercise are among what public health experts describe as the social determinants of health .

Americans across different traits and demographic characteristics hold largely similar views on what affects a person’s weight. There are some modest differences in views by self-described weight: Adults who say they are very or slightly overweight are 11 points more likely to say stress and anxiety affects a person’s weight a great deal than those who describe their weight as about right (40% vs. 29%).

Men and women largely agree on the factors influencing weight. For instance, diet tops the list for both men and women.

Dot plot showing that women are more likely than men to say stress and anxiety affects a person’s weight a great deal.

Still, women are more likely than men to emphasize the role of stress and anxiety.   

Women are about as likely to say stress and anxiety affects a person’s weight a great deal as to say exercise has this level of impact (42% vs. 40%). Black and Hispanic women are especially likely to emphasize the impact of stress and anxiety on weight.

By contrast, men place more emphasis on exercise habits than stress and anxiety when it comes to factors that affect a person’s weight a great deal (46% vs. 29%).

  • Blum, Dani. “ What Is Ozempic and Why Is It Getting So Much Attention? ” Nov. 13, 2023. The New York Times. ↩
  • Rapaport, Lisa. “ Ozempic Shortage: How a Weight Loss Fad Has Slashed Access to a Diabetes Drug. ” Dec. 4, 2023. Everyday Health ↩
  • Couzin-Frankel, Jennifer. “ Obesity meets its match. ” Dec. 14, 2023. Science. ↩

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Ozempic may be linked to condition that causes blindness, but more research is needed

People taking Ozempic and Wegovy may be at increased risk of developing a debilitating eye condition that can cause irreversible vision loss, a study published Wednesday in JAMA Ophthalmology finds. The authors stressed, however, that more studies are needed to confirm a link between the blockbuster drugs and vision problems.

Non-arteritic anterior ischemic optic neuropathy, or NAION , is a condition that affects the optic nerve, a bundle of fibers that connects to the back of the eye and carries signals to the brain so a person can see. In people with NAION, blood flow to the optic nerve gets reduced or blocked, leading to sudden vision loss.

“It is, in effect, a stroke of the optic nerve,” said senior study author Dr. Joseph Rizzo, the director of neuro-ophthalmology at Mass Eye and Ear in Boston.

NAION is the second most common optic nerve disease in the U.S., occurring in up to 10 out of 100,000 people, according to the American Academy of Ophthalmology , and it’s one of the most common causes of sudden blindness. The condition is permanent with no known treatment. 

The new study was based on an analysis of medical records spanning six years from more than 16,800 patients in the Boston area, none of whom were initially diagnosed with NAION. 

The researchers focused on a subset of those patients — about 1,700 — who either had diabetes, were overweight or had obesity, and compared outcomes after 36 months in those who were prescribed semaglutide to those who weren’t. Semaglutide is the ingredient in Ozempic and Wegovy . 

Almost 200 of the diabetes patients were prescribed semaglutide and 17 went on to develop NAION, a rate more than four times higher than those not prescribed the drug. For the obesity group, 361 people were prescribed semaglutide and 20 people developed the condition, a seven times higher rate. 

Rizzo said that because the findings were based on a review of existing data, researchers can’t say for sure whether semaglutide causes the eye condition. He said a large, randomized controlled clinical trial is still needed to confirm a link. 

“What it does show is an association between taking semaglutide and developing this condition where you lose vision,” he said. 

Dr. Andrew Lee, clinical spokesperson for the American Academy of Ophthalmology and a neuro-ophthalmologist at Houston Methodist Hospital, said he's had some patients who developed NAION who were taking semaglutide , but the question was always whether “this is a causal association or merely an association alone.” 

People with Type 2 diabetes are already at an increased risk for vision problems, including NAION. Another vision problem, diabetic retinopathy, is the leading cause of blindness in adults and is caused by damage to the retina from high blood sugar levels.

What’s more, risk factors for NAION include sleep apnea and hypertension, which are diseases that are more likely to occur in people with obesity. 

Lee said that it’s plausible that weight loss medications could cause the condition, however, it is “premature to conclude” a link based on the single study. “The ​​study can only generate the hypothesis” of a possible link, he said. 

There have been some anecdotal reports suggesting that weight loss drugs may be linked to vision problems, including blurred or warped vision. 

Rizzo said it’s unclear how the weight loss drugs could cause the condition. It could be due to some mechanism with the class of drugs, called GLP-1s , broadly, he said, or something specific to the way semaglutide works. (The study only looked at semaglutide and not other popular weight loss medications such as tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound.)

Dr. Susan Mollan, a consultant neuro-ophthalmologist at the University Hospitals Birmingham in the United Kingdom, wrote in an email that past trials in people with diabetes have shown that when a patient’s blood sugar control is tightened, “they may have a paradoxical worsening of their diabetic retinopathy (temporarily),” so it’s plausible that the GLP-1 drugs, which also help control blood sugar, could “have a paradoxical biological effect.” Mollan wrote an editorial that was published alongside the new study.

Rizzo said patients should speak with their doctor if they are concerned about developing the potential health condition.

“As someone who sees patients who have diseases like this, if someone already has visual loss for whatever reason, and they were wondering whether they would go on semaglutide, I would just have added caution,” Rizzo said.

Dr. Shauna Levy, a specialist in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans, said the findings won’t change how she prescribes the drugs.

“As for now, the risk still seems low,” she said. 

In a statement, a spokesperson for Novo Nordisk said the study is not sufficient to establish a link between semaglutide and the condition.

“Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from the use of our medicines very seriously,” the spokesperson said.

new research on ozempic

Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.

Are Bacteria The New Ozempic? Research Finds Promising Gut Microbe That Could Help Fight Obesity

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Researchers have discovered gut microbes that could one day be harnessed to help diagnose, prevent and treat conditions like obesity, prediabetes and type 2 diabetes, according to research published Wednesday in Nature , the latest breakthrough in our understanding of the human microbiome that promises to unlock a new era of medical innovation.

Gut bacteria signal promise for new treatments for obesity and diabetes, research suggests.

Certain bacteria were found to be more common in the poop of people with higher insulin resistance, according to an analysis of fecal samples provided by more than 300 adults at their regular health checkups, which give an insight into the gut microbiome, the trillions of bacteria living inside of us that are thought to have a profound impact on our health.

Resistance to insulin—a hormone that helps regulate blood sugar levels—means more sugar remains in the blood and can lead to weight gain, prediabetes (a serious condition of elevated blood sugar that doesn’t warrant a diabetes diagnosis) and type 2 diabetes.

The researchers, led by Hiroshi Ohno at the RIKEN Center for Integrative Medical Sciences in Japan, noted that the microbiome of people with higher levels of carbohydrates (sugars) in their feces and higher insulin resistance were dominated by Lachnospiraceae bacteria.

Conversely, the microbiome of people with lower insulin resistance and lower fecal carbohydrates contained more Bacteroidales bacteria than other types.

By growing the bacteria in a lab, the researchers sought to identify species common in people with low insulin resistance that could be used to bring down blood sugar levels in people resistant to insulin, which they then tested in obese mice.

The approach—particularly with a Bacteroidales species called Alistipes indistinctus —was promising, the researchers said, lowering blood sugar, leading to “significantly improved” insulin resistance and lowering the amount of carbohydrates available to the mice.

Crucial Quote

The study signposts a number of potential avenues that could be explored for future therapies and diagnostic tools in humans, said Ohno. As Lachnospiraceae bacteria are associated with insulin resistance, Ohno said they could be a good thing to test for to indicate prediabetes. “Likewise, treatment with probiotics containing A. indistinctus might improve glucose intolerance in those with pre-diabetes,” Ohno said. Though the study suggests promising avenues for future work, Ohno stressed they “need to be verified in human clinical trials before” any probiotic can be recommended as a treatment for insulin resistance.

What To Watch For

Tadashi Takeuchi, a researcher at Stanford University and first author of the study, told Forbes the group is analyzing other associations between the gut microbiome and metabolism. Takeuchi stressed there are also a number of challenges that must be overcome in order to bring Lachnospiraceae bacteria to clinics. For example, Takeuchi said the group contains a “wide array of gut bacterial species” and more research is needed to outline what they do and to identify how they can be used to indicate dysfunctions like prediabetes. This work could be challenging, Takeuchi warned, explaining that the characteristics of Lachnospiraceae bacteria are “largely unknown” because their “extreme sensitivity to oxygen” makes them difficult to culture in labs. This sensitivity would also hinder efforts to develop A. indistinctus as a commercial probiotic, Takeuchi said, adding that to his knowledge no commercial products contain the strain.

Key Background

A variety of treatments have emerged as our understanding of the gut microbiome and its role in health has developed. Fecal transplants, which involve placing stool and bacteria from healthy donors into a sick individual, have been used to treat potentially lethal infections like C. difficile for years now. Researchers are looking into applying the insights to a variety of issues like obesity, Crohn's disease and allergies, as well as making treatment easier through the use of fecal pills. The Food and Drug Administration approved the first fecal pill—made of healthy gut bacteria found in feces to combat C. diff—targeting the microbiome in April, a step towards boosting access to fecal transplants.

The possibility of applying what we know about gut microbes to build new ways of treating obesity comes amid an explosion of drugs doing the very same. Drugs like semaglutide—marketed as Ozempic and Wegovy—and Mounjaro are at the leading edge of a wave of new pharmaceutical weight loss options that experts say will be a game changer for tackling obesity. Demand for the drugs, fueled by the promise of tackling one of the biggest public health threats of our time, is so strong that the companies producing them are struggling to keep up. Novo Nordisk, which produces Ozempic and Wegovy, has admitted supplies are likely to be limited for years to come as it struggles to ramp up production to meet stellar demand. The drugs are slated to become some of the best selling drugs of all time.

Further Reading

I Contain Multitudes (Book by Ed Yong)

Does the microbiome hold the key to chronic fatigue syndrome? (Observer)

Unlocking the ‘gut microbiome’ – and its massive significance to our health (Guardian)

Robert Hart

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Ozempic can improve a common, chronic skin condition, new study claims

Add this common skin condition to the list of ailments that Ozempic may improve.

Hidradenitis suppurativa (HS) is a lesion-causing inflammatory disorder that affects at least 1 in 100 people and is strongly associated with obesity.

Treatments include weight loss, antibiotics, anti-inflammatory drugs, surgery and laser therapy — and perhaps eventually semaglutide , the active ingredient in Ozempic and Wegovy.

In a new study , 30 obese patients with varying levels of HS received semaglutide weekly for about eight months.

Participants lost 13 pounds on average, improved their blood sugar, reduced inflammation in their body and experienced fewer HS flare-ups.

On average, the frequency of these episodes went from once every 8 ½ weeks to once every 12 weeks.

The results were presented this week at the European Academy of Dermatology and Venereology conference in Amsterdam.

“Our findings suggest that semaglutide, even at modest doses, can offer substantial benefits in managing HS,” said Dr. Daniel Lyons , lead researcher from St. Vincent’s University Hospital in Dublin, Ireland.

“While the drug’s role in promoting weight loss is well-established, what’s particularly exciting is its potential to also reduce the frequency of HS flare-ups, contributing to the notable improvements observed in patients’ quality of life,” Lyons added.

He says larger trials are needed to confirm these findings and assess the effect of higher doses of semaglutide.

“Ultimately, we hope our preliminary data will encourage dermatologists to consider weight loss medication as an adjunct to existing HS treatments and inspire further research in this area aimed at improving outcomes for people living with this challenging condition,” Lyons said.

The US Food and Drug Administration approved Ozempic in 2017 to treat Type 2 diabetes in adults and Wegovy in 2021 for adult weight loss.

Since then, researchers have been scrambling to figure out  what else Ozempic and similar drugs can treat , such as  substance abuse and heart disease .

Drugs like Ozempic have upended how we treat obesity and diabetes.

Doctors and drugmakers say we’re just starting to understand these drugs — and how else they might change medicine.

There are now dozens of clinical trials underway to explore what other diseases they could treat.

Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome

Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

Alcohol use disorder

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

Sleep apnea

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)

Kidney disease

Clinical Trial Studying Possible New Treatment Option for Patients with NAFLD

Semaglutide for Alcohol Use Disorder

poster for video

A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis

Semaglutide Therapy for Alcohol Reduction - Tulsa (STAR-T)

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

Cardiovascular

Semaglutide Treatment of Excessive Body Weight in Obese PCOS Patients Unresponsive to Lifestyle Programs

Semaglutide Therapy for Alcohol Reduction (STAR)

Significant Decrease in Alcohol Use Disorder Symptoms Secondary to Semaglutide Therapy for Weight Loss: A Case Series

Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

0567 Tirzepatide for the Treatment of OSA: Rationale and Design of the SURMOUNT-OSA Phase 3 Trial

A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Treating PCOS With Semaglutide vs Active Lifestyle Intervention

What’s Next for Ozempic?

By Dani Blum Dec. 20, 2023

Ozempic and other drugs like it have proven powerful at regulating blood sugar and driving weight loss. Now, scientists are exploring whether they might be just as transformative in treating a wide range of other conditions, from addiction and liver disease to a common cause of infertility.

“It’s like a snowball that turned into an avalanche,” said Lindsay Allen, a health economist at Northwestern Medicine. As the drugs gain momentum, she said, “they’re leaving behind them this completely reshaped landscape.”

Much of the research on other uses of semaglutide, the compound in Ozempic and Wegovy, and tirzepatide, the substance in Mounjaro and Zepbound, is only in the early stages. One of the biggest questions scientists are seeking to answer: Do the benefits of these drugs just boil down to weight loss? Or do they have other effects, like tamping down inflammation in the body or quieting the brain’s compulsive thoughts, that would make it possible to treat far more illnesses?

We won’t likely know anytime soon. “We’re still learning how these medicines work,” said Dr. Daniel Drucker, one of the first researchers to study these drugs. (Dr. Drucker consults for Novo Nordisk, the company that makes Ozempic and Wegovy.)

People with the conditions below, many of whom have few good options for treatment, could benefit in the long run if these trials are successful. And for weight-loss drugmakers, every new use could catapult the drugs even further into blockbuster status. Some of these applications — including for heart disease and sleep apnea, which each affects tens of millions of people — have become targets for these companies and could prove especially lucrative. These medications are a “gold mine,” Dr. Allen said. “There is no upper bound for where the market is going.”

As evidence emerges from these studies, researchers will get a clearer idea of how, exactly, these drugs work in the body. If they can treat even more diseases, they could shake up medicine all over again.

Alcohol use disorder, also known as alcoholism, is common — nearly 30 million people in the United States had the condition in 2022. But it’s rare for people to get diagnosed , and often extraordinarily difficult for them to find treatment. There are effective medications on the market, but some people who could benefit from them aren’t even aware that they exist.

The potential

Anecdotally, some people who take drugs like Ozempic say the medications make them want to drink less , and in some cases, turn them off alcohol altogether. Researchers are trying to untangle why. Because people feel full when they take these medications, they may lose interest in alcohol as well as in food. It’s also possible that because these drugs target parts of the brain that regulate appetite, they could also affect compulsive behaviors that might involve those brain regions, like using alcohol or stimulants, gambling, smoking or even nail-biting.

The early evidence

One small study followed six people with alcohol use disorder who were taking semaglutide for weight loss. All six drank significantly less after they had been on the drug for between one and nine months. In an online survey of 153 adults with obesity, most of whom were white and women, those who took semaglutide or tirzepatide reported drinking significantly less than peers not on the medications.

While data are limited, some patients with alcohol use disorder have already started asking doctors about these drugs. Researchers studying how these medications affect drinking recently responded to that demand with a piece in Nature Medicine, urging doctors not to use the drugs for alcohol use disorder without more research.

Polycystic ovary syndrome

As many as five million people in the United States have polycystic ovary syndrome, or PCOS . The condition is a leading cause of infertility and causes irregular periods. There are treatments available — diet and exercise changes, birth control pills and the diabetes drug metformin — but they don’t work for everyone.

Researchers believe that high testosterone levels contribute to PCOS. When people with the condition lose weight, their testosterone levels often decline. Drugs like Ozempic could help regulate hormones in people with PCOS, said Dr. Melanie Cree, who is leading one of the earliest studies to investigate whether semaglutide can resolve PCOS symptoms.

A small study of 27 people with obesity and PCOS who took a low dose of semaglutide found that after six months, most participants had lost weight and had more regular periods, suggesting their PCOS was under better control. Dr. Cree completed a study of semaglutide in adolescent girls with PCOS that showed similar results, and she is recruiting for another focused on period regularity.

Liver disease

Up to 70 percent of people with Type 2 diabetes and between 50 and 90 percent of people with obesity have nonalcoholic fatty liver disease, or NAFLD, which occurs when excess fat builds up in the liver. The condition can cause liver damage so severe that some patients end up needing liver transplants.

Doctors typically urge obese or overweight patients with NAFLD to lose weight in order to lower the amount of fat and inflammation in the liver. Because drugs like Ozempic lead people to lose weight, they may also decrease the amount of fat stored in the liver. Type 2 diabetes also increases the risk of NAFLD. By treating it, drugs like Ozempic may also reduce the risk or severity of liver disease.

Scientists have two other theories about how the drugs might help: by improving the insulin resistance common in people with NAFLD and lowering inflammation that can damage the liver.

A Novo Nordisk-funded study found that compared to placebo, semaglutide didn’t significantly improve liver scarring or resolution of nonalcoholic steatohepatitis, or NASH, a severe form of nonalcoholic fatty liver disease. The study included people with cirrhosis, or scarred and permanently damaged livers. A larger Novo Nordisk-funded trial found that patients in earlier stages taking semaglutide were more likely than those on a placebo to see their NASH resolved, but not significantly more likely to see their scarring improve.

Novo Nordisk is now running an even bigger clinical trial on semaglutide and NASH, and the Food and Drug Administration has designated the drug a “breakthrough therapy” for the disease, which will expedite regulatory review. Researchers funded by Eli Lilly are also investigating whether tirzepatide can treat NASH.

Cardiovascular issues

Heart disease killed nearly 700,000 people in the United States in 2022, making it the country’s leading cause of death. Experts say there’s an urgent need for new therapies that can reduce the risk of heart attacks and strokes and improve symptoms like fatigue and shortness of breath that can make it difficult for people with heart disease to get through the day.

Obesity significantly raises the risk of cardiovascular disease, which is why some doctors think that losing weight might treat and prevent heart issues. The drugs may also be able to help by lowering inflammation, which may lead plaque to form in the heart and trigger blood clots.

In November, a major trial showed that semaglutide lowered the risk of events like heart attacks and strokes by 20 percent among obese and overweight people with heart disease. Another trial of people with obesity and a certain type of heart failure found that semaglutide could improve symptoms and make it easier to exercise. Eli Lilly is conducting its own trial on tirzepatide and heart failure. And more studies are in the pipeline: Researchers are examining whether semaglutide can reduce plaque in the heart , improve symptoms of heart failure or reduce damage from strokes .

An estimated 30 million people in the United States suffer from obstructive sleep apnea, in which breathing repeatedly stops and starts during sleep. Treatments like the use of continuous positive airway pressure, or CPAP, machines can help, although patients often find them uncomfortable. Many with sleep apnea are undiagnosed. If it isn’t properly treated, the condition can take a significant toll on people’s health and can raise the risk of complications like heart disease and Type 2 diabetes.

Sleep apnea is more common among people with obesity. That’s due to a complex set of factors, including that deposits of fat in the neck can clog the airway when a person is lying down. Research has shown weight loss, including through bariatric surgery , can help.

There’s very little data so far, though a spokesperson for Eli Lilly said the company expected to complete a study of tirzepatide and sleep apnea in the spring of 2024. Novo Nordisk is not currently studying whether semaglutide can treat sleep apnea.

Roughly one in three adults with Type 2 diabetes also has chronic kidney disease, which occurs when the kidneys are damaged and can’t function properly. Patients with the disease may ultimately need dialysis or a kidney transplant, and if it goes untreated, the condition can be fatal.

Kidney damage happens slowly over time and is irreversible in almost all cases, said Dr. George Bakris, who was involved in a trial of semaglutide in people with Type 2 diabetes and chronic kidney disease that was backed by Novo Nordisk. Drugs like Ozempic may be able to prevent further damage, partly because weight loss reduces the risk of hypertension and Type 2 diabetes, which are risk factors for chronic kidney disease.

It is not totally clear how else these drugs might improve chronic kidney disease, but one potential factor is that they might reduce inflammation, which can be harmfully high in people with the condition.

Novo Nordisk announced in October that it had halted a trial of semaglutide in people with Type 2 diabetes and chronic kidney disease after an early analysis made clear the drug was effective, though the company has not yet released the data. The company is funding another study to examine how semaglutide works in the kidneys. Eli Lilly is funding a trial of tirzepatide in people with obesity and chronic kidney disease.

These and other studies are part of what Dr. Howard Forman, a professor at the Yale School of Medicine who specializes in health policy, calls “an explosion of opportunities.”

Whether those opportunities can become new treatments remains to be seen.

“We are on the very, very early upsweep of this whole industry,” Dr. Forman said, “and nothing will surprise me.”

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Novo Nordisk CEO takes aim at U.S. healthcare as he defends Ozempic pricing to Bernie Sanders

In this article:.

Novo Nordisk’s meteoric rise has been met with a wave of ringing endorsements from customers who have seen years of struggles with obesity solved in a flash with the help of Ozempic and Wegovy. At least, that’s the opinion of those who can afford or even access the pricey drugs.

Novo Nordisk CEO Lars Fruergaard Jørgensen called out Americans’ struggles to navigate the “complex U.S. healthcare system” and that “no company alone could solve such vast and complicated policy challenges,” defending the price of his weight loss-aiding drugs that vastly outstrip prices in Europe and the U.K.

Jørgensen was on the offensive on Tuesday after challenges from Bernie Sanders, who in May urged Novo Nordisk to “ help the American people ” by reducing its profit ambitions to faster address a diabetes and obesity epidemic in the U.S.

Jørgensen goes on the offensive

GLP-1 drugs have historically been used to treat type 2 diabetes, but in the last few years, they have exploded in popularity for their ability to induce dramatic weight loss.

Novo Nordisk, which makes Ozempic, Wegovy, and Semaglutide, has increased in value by more than 240% since the start of 2021, while annual sales rose by 65% between 2021 and 2023.

The pharmaceutical group’s market value eclipsed the annual GDP of its native Denmark last year, and policymakers regularly name-check Novo, noting the group’s influence on the country’s financial system. Its drugs are also regarded as a genuine silver bullet to addressing a long-running obesity crisis in the Western world.

However, that growing hype, particularly in the U.S., has invited scrutiny from lawmakers.

Jørgensen volunteered to testify before the Senate Committee on Health, Education, Labor, and Pensions (HELP) on Novo’s pricing disparity in the U.S. after facing criticism from senators, including HELP chair Bernie Sanders. The committee initially planned to force its president, Doug Langa, to testify before Jørgensen volunteered.

Consumers in the States face paying orders of magnitude more for Ozempic and Wegovy than people in the U.K. and the rest of Europe. Wegovy’s over-the-counter price, for example, is 1,300% more expensive in the U.S. than in the U.K.

In written testimony, however, Jørgensen said 90% of U.S. patients with healthcare coverage were paying less than $50 per month for Ozempic and Wegovy. He added that Ozempic is covered by 99% of commercial plans and Medicare and Medicaid in all 50 States.

Wegovy is covered by 50% of commercial plans and in 20 Medicaid states, leaving considerable affordability gaps.

“However, the complexities of the system unfortunately reduce access and affordability for many Americans,” Jørgensen said. “We are eager to work with this Committee to address these systemic issues so that everyone who can benefit from our medicines is able to get them.”

Giving oral testimony to the Sanders-led HELP committee, Jørgensen said: “You have said that our amazing medicines can’t help patients if they can’t afford them. That is true. It is also true that the true value of Ozempic and Wegovy can only be realized if patients can access them. Patients need both affordability and access.”

Jørgensen’s testimony was months in the making, and tensions were fomented in the interim following inflammatory rhetoric by Bernie Sanders and other U.S. politicians.

Sanders blasted Novo Nordisk after a HELP Committee investigation found the Danish giant was charging Americans $1,349 for a month’s supply of Wegovy while people in the U.K. were being charged just $92.

“The American people are sick and tired of being ripped off by giant pharmaceutical companies who make huge profits every year while charging us outrageous prices,” Sanders said in June.

“It’s obvious. It’s simple. We want Novo Nordisk to stop ripping off the American people and charging us prices that are far higher than they charge in other countries.”

In Jørgensen’s comments to the committee, he was keen to put into perspective Novo’s contribution to obesity reduction in the U.S. compared with the public sector.

The Novo CEO noted that his company spent $4.2 billion on diabetes and obesity research and development last year, 50% more than the U.S.’s leading research body, the National Institutes for Health.

The group has committed to expanding its production capacity in the U.S., a response to demand outstripping supply of GLP-1s after consumers began buying up stock in the wake of the drugs’ weight loss revelations.

The Novo boss highlighted his group’s pledge to spend $30 billion to expand production capacity worldwide.

Jørgensen added in his written testimony that Ozempic would be eligible for price negotiations with customers, including Medicare, from next year.

This, Jørgensen said, would likely bring down the price of Ozempic. He noted that the net price of Ozempic—the price Novo Nordisk is paid for its medicines—has declined by 40% since its introduction to the U.S. in 2018.

This story was originally featured on Fortune.com

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Breaking news, ozempic can improve a common, chronic skin condition, new study claims.

Add this common skin condition to the list of ailments that Ozempic may improve.

Hidradenitis suppurativa (HS) is a lesion-causing inflammatory disorder that affects at least 1 in 100 people and is strongly associated with obesity.

Treatments include weight loss, antibiotics, anti-inflammatory drugs, surgery and laser therapy — and perhaps eventually semaglutide , the active ingredient in Ozempic and Wegovy.

New research finds that semaglutide, the active ingredient in Ozempic and Wegovy, may help manage the skin condition hidradenitis suppurativa.

In a new study , 30 obese patients with varying levels of HS received semaglutide weekly for about eight months.

Participants lost 13 pounds on average, improved their blood sugar, reduced inflammation in their body and experienced fewer HS flare-ups.

Participants lost 13 pounds on average over eight months, improved their blood sugar, reduced inflammation in their body and experienced fewer HS flare-ups.

On average, the frequency of these episodes went from once every 8 ½ weeks to once every 12 weeks.

The results were presented this week at the European Academy of Dermatology and Venereology conference in Amsterdam.

“Our findings suggest that semaglutide, even at modest doses, can offer substantial benefits in managing HS,” said Dr. Daniel Lyons , lead researcher from St. Vincent’s University Hospital in Dublin, Ireland.

“While the drug’s role in promoting weight loss is well-established, what’s particularly exciting is its potential to also reduce the frequency of HS flare-ups, contributing to the notable improvements observed in patients’ quality of life,” Lyons added.

He says larger trials are needed to confirm these findings and assess the effect of higher doses of semaglutide.

“Ultimately, we hope our preliminary data will encourage dermatologists to consider weight loss medication as an adjunct to existing HS treatments and inspire further research in this area aimed at improving outcomes for people living with this challenging condition,” Lyons said.

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The US Food and Drug Administration approved Ozempic in 2017 to treat Type 2 diabetes in adults and Wegovy in 2021 for adult weight loss.

Since then, researchers have been scrambling to figure out  what else Ozempic and similar drugs can treat , such as  substance abuse and heart disease .

New research finds that semaglutide, the active ingredient in Ozempic and Wegovy, may help manage the skin condition hidradenitis suppurativa.

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COMMENTS

  1. New study ties weight-loss drugs Wegovy, Ozempic to serious

    A study published in JAMA found that GLP-1 inhibitor drugs, including Ozempic and Wegovy, may increase the risk of pancreatitis, intestinal blockage and stomach paralysis compared to an older obesity drug. Health Canada and other regulators are reviewing the safety of these medications, which are used for diabetes and weight loss.

  2. Two-year effects of semaglutide in adults with overweight or obesity

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  3. Once-Weekly Semaglutide in Adults with Overweight or Obesity

    Our trial showed that among adults with overweight or obesity (without diabetes), once-weekly subcutaneous semaglutide plus lifestyle intervention was associated with substantial, sustained ...

  4. Ozempic May Help Treat Kidney Disease, Study Finds

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  5. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes

    The SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med 2015;373:2103-2116. Crossref. ... New York: Springer, 1993. Crossref.

  6. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic

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    Medical specialists say the latest to offer that possibility are the new drugs that treat obesity — Ozempic, Wegovy, Mounjaro and more that may soon be coming onto the market. ... Research into ...

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    The higher the dose of oral semaglutide, the more side effects seem to come with it. In the trial of people who were overweight or obese, 80 percent of those who took oral semaglutide reported ...

  10. Ozempic reduces risk of serious illness and death in people with ...

    Weekly injections of semaglutide medications like Ozempic significantly reduce the risk of serious kidney outcomes, major cardiovascular events and death among people who have type 2 diabetes and ...

  11. Ozempic weight loss: Jabs could slow ageing, researchers say

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    In June of 2021, the US Food and Drug Administration (FDA) approved the drug semaglutide for chronic weight management under the brand name Wegovy, ushering in a new era of obesity treatment. Since then, demand for Wegovy and the type 2 diabetes therapy Ozempic—which contains the same drug and has commonly been prescribed off-label for weight loss—have outpaced production, causing ongoing ...

  13. Ozempic, Wegovy linked to severe medical conditions ...

    Oct. 5, 2023, 8:20 AM PDT. By Berkeley Lovelace Jr. People who take popular drugs for weight loss, such as Ozempic or Wegovy, may be at an increased risk of severe stomach problems, research ...

  14. Beyond Ozempic: Trials Hold Promise of Highly Effective Obesity Drugs

    Semaglutide, also known by its brand names Ozempic and Wegovy, marks a new era in anti-obesity therapeutics. The unprecedented drug offers a safe and effective option for patients that addresses the root of obesity. ... First, prior research has shown that individuals with type 2 diabetes generally lose less weight than those with obesity alone ...

  15. More fiber in the diet may help boost levels of GLP-1, an Ozempic-like

    More fiber in the diet may help boost levels of GLP-1, an Ozempic-like hormone : Shots - Health News Popular weight-loss drugs mimic GLP-1, a hormone the body makes naturally after eating. Turns ...

  16. The surprising mental health and brain benefits of ...

    New research is revealing the surprising brain and mental health benefits of semaglutide drugs such as Ozempic and Wegovy, and other related diabetes and weight-loss drugs that mimic a gut hormone ...

  17. Your Body Has Its Own Built-In Ozempic

    The following essay is reprinted with permission from The Conversation, an online publication covering the latest research.. Wegovy, Ozempic and Mounjaro are weight loss and diabetes drugs that ...

  18. US Views of Weight-Loss Drugs Like Ozempic ...

    A new Pew Research Center survey examines Americans' attitudes about a new class of drugs being used for weight loss, including Ozempic and Wegovy. In this report, we cover views of: The use of weight-loss drugs; The impact of weight-loss drugs on obesity in America; The factors that impact a person's weight, including the role of willpower

  19. e new england journal o medicine

    990 n engl j med 384;11 nejm.org March 18, 2021 The new england journal of medicine O besity is a chronic disease and global public health challenge. 1-3 Obesity can lead to insulin resistance ...

  20. Ozempic may be linked to condition that causes blindness ...

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  21. Are Bacteria The New Ozempic? Research Finds Promising Gut ...

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  22. Ozempic can improve a common, chronic skin condition, new study ...

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  23. What's Next for Ozempic?

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  24. Women Are Losing More Weight On Ozempic—And Scientists Are ...

    A new study published in JAMA Network Open contends that women may lose more weight on semaglutides like Ozempic than men. Here's why, according to doctors. ... new research found that, on average ...

  25. Novo Nordisk CEO takes aim at U.S. healthcare as he defends Ozempic

    The Novo CEO noted that his company spent $4.2 billion on diabetes and obesity research and development last year, 50% more than the U.S.'s leading research body, the National Institutes for Health.

  26. 'Greed, greed, greed': Sanders demands Ozempic maker lower prices

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  27. Once-Weekly Semaglutide in Adolescents with Obesity

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  28. Ozempic, Wegovy maker Novo Nordisk questioned over high cost of ...

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  29. Ozempic can improve a common, chronic skin condition, new study claims

    New research finds that semaglutide, the active ingredient in Ozempic and Wegovy, may help manage the skin condition hidradenitis suppurativa. ... The US Food and Drug Administration approved ...

  30. Ozempic, Wegovy Price in Focus as Novo Nordisk Faces Bernie Sanders

    Ozempic and Wegovy are making so much money for Novo Nordisk A/S that their cumulative sales will soon surpass the drugmaker's entire research budget for the past three decades, undercutting a ...