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Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes

赛马鲁肽 利拉鲁肽 医学 安慰剂 超重 内科学 体质指数 不利影响 随机对照试验 减肥 物理疗法
作者
Domenica Rubino,Frank L. Greenway,Usman Khalid,Patrick M. O’Neil,Julio Rosenstock,Rasmus Sørrig,Thomas A. Wadden,Alicja Wizert,W. Timothy Garvey,Carlos Arauz-Pacheco,Kevin Cannon,H. Jackson Downey,David Fitz-Patrick,Jeffrey Geohas,Gregg Gerety,John Gilbert,Priscilla Hollander,Eric Klein,Karen Laufer,Philip O'Donnell,Paul Rosenblit,Phillip Toth,
出处
期刊:JAMA [American Medical Association]
卷期号:327 (2): 138-138 被引量:8
标识
DOI:10.1001/jama.2021.23619
摘要

Importance

Phase 3 trials have not compared semaglutide and liraglutide, glucagon-like peptide-1 analogues available for weight management.

Objective

To compare the efficacy and adverse event profiles of once-weekly subcutaneous semaglutide, 2.4 mg, vs once-daily subcutaneous liraglutide, 3.0 mg (both with diet and physical activity), in people with overweight or obesity.

Design, Setting, and Participants

Randomized, open-label, 68-week, phase 3b trial conducted at 19 US sites from September 2019 (enrollment: September 11-November 26) to May 2021 (end of follow-up: May 11) in adults with body mass index of 30 or greater or 27 or greater with 1 or more weight-related comorbidities, without diabetes (N = 338).

Interventions

Participants were randomized (3:1:3:1) to receive once-weekly subcutaneous semaglutide, 2.4 mg (16-week escalation; n = 126), or matching placebo, or once-daily subcutaneous liraglutide, 3.0 mg (4-week escalation; n = 127), or matching placebo, plus diet and physical activity. Participants unable to tolerate 2.4 mg of semaglutide could receive 1.7 mg; participants unable to tolerate 3.0 mg of liraglutide discontinued treatment and could restart the 4-week titration. Placebo groups were pooled (n = 85).

Main Outcomes and Measures

The primary end point was percentage change in body weight, and confirmatory secondary end points were achievement of 10% or more, 15% or more, and 20% or more weight loss, assessed for semaglutide vs liraglutide at week 68. Semaglutide vs liraglutide comparisons were open-label, with active treatment groups double-blinded against matched placebo groups. Comparisons of active treatments vs pooled placebo were supportive secondary end points.

Results

Of 338 randomized participants (mean [SD] age, 49 [13] years; 265 women [78.4%]; mean [SD] body weight, 104.5 [23.8] kg; mean [SD] body mass index, 37.5 [6.8]), 319 (94.4%) completed the trial, and 271 (80.2%) completed treatment. The mean weight change from baseline was –15.8% with semaglutide vs –6.4% with liraglutide (difference, –9.4 percentage points [95% CI, –12.0 to –6.8];P < .001); weight change with pooled placebo was –1.9%. Participants had significantly greater odds of achieving 10% or more, 15% or more, and 20% or more weight loss with semaglutide vs liraglutide (70.9% of participants vs 25.6% [odds ratio, 6.3 {95% CI, 3.5 to 11.2}], 55.6% vs 12.0% [odds ratio, 7.9 {95% CI, 4.1 to 15.4}], and 38.5% vs 6.0% [odds ratio, 8.2 {95% CI, 3.5 to 19.1}], respectively; allP < .001). Proportions of participants discontinuing treatment for any reason were 13.5% with semaglutide and 27.6% with liraglutide. Gastrointestinal adverse events were reported by 84.1% with semaglutide and 82.7% with liraglutide.

Conclusions and Relevance

Among adults with overweight or obesity without diabetes, once-weekly subcutaneous semaglutide compared with once-daily subcutaneous liraglutide, added to counseling for diet and physical activity, resulted in significantly greater weight loss at 68 weeks.

Trial Registration

ClinicalTrials.gov Identifier:NCT04074161
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