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

• DOI: 10.1001/jama.2021.23619
• Publication Date: 2022-01-11T16:01:49Z
• Authors: Domenica M. 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
• Keywords: Semaglutide; Clinical endpoint; Subcutaneous injection

InvestigatorsIMPORTANCE Phase 3 trials have not compared semaglutide and liraglutide, glucagon-like peptide-1 analogues available for weight management.OBJECTIVE To compare the efficacy adverse event profiles of once-weekly subcutaneous semaglutide, 2.4 mg, vs once-daily 3.0 mg (both with diet physical activity), in people overweight or obesity.DESIGN, SETTING, AND PARTICIPANTS Randomized, open-label, 68-week, phase 3b trial conducted at 19 US sites from September 2019 (enrollment: 11-November 26) to May 2021 (end follow-up: 11) adults body mass index 30 greater 27 1 more weight-related comorbidities, without diabetes (N = 338).INTERVENTIONS Participants were randomized (3:1:3:1) receive (16-week escalation; n 126), matching placebo, (4-week 127), plus activity.Participants unable tolerate could 1.7 mg; participants liraglutide discontinued treatment restart 4-week titration.Placebo groups pooled (n 85). MAIN OUTCOMES MEASURESThe primary end point was percentage change weight, confirmatory secondary points achievement 10% more, 15% 20% loss, assessed week 68.Semaglutide comparisons active double-blinded against matched placebo groups.Comparisons treatments supportive points. RESULTSOf 338 (mean [SD] age, 49 [13] years; 265 women [78.4%]; mean 104.5 [23.8] kg; index, 37.5 [6.8]), 319 (94.4%) completed trial, 271 (80.2%) treatment.The baseline -15.8% -6.4% (difference, -9.4 [95% CI, -12.0 -6.8]; P < .001);weight -1.9%.Participants had significantly odds achieving loss (70.9% 25.6% [odds ratio, 6.3 {95% 3.5 11.2}], 55.6% 12.0% 7.9 4.1 15.4}], 38.5% 6.0% 8.2 19.1}], respectively; all .001).Proportions discontinuing any reason 13.5% 27.6% liraglutide.Gastrointestinal events reported by 84.1% 82.7% liraglutide.CONCLUSIONS RELEVANCE Among obesity diabetes, added counseling activity, resulted 68 weeks.