Efficacy and safety of once-weekly semaglutide 2.4 mg for weight management in participants from China: A prespecified analysis of the STEP 7 randomized clinical trial

Abstract

Aim: To evaluate the efficacy and safety of semaglutide 2.4 mg versus placebo for weight management in a population of Chinese adults with overweight or obesity. Materials and Methods: In STEP 7 (NCT04251156), a double-blind, phase 3a trial, adults from a predominantly East Asian population with overweight or obesity, with or without type 2 diabetes, were randomized 2:1 to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 44 weeks as an adjunct to a reduced-calorie diet and increased physical activity. This prespecified analysis evaluated Chinese participants in STEP 7. The primary endpoints were percentage change in body weight from baseline to Week 44 and the proportion of participants who achieved ≥5% reduction in body weight from baseline. Results: Overall, 195 Chinese participants were randomized to semaglutide 2.4 mg and 105 to placebo. Estimated change in mean body weight from baseline to Week 44 was −11.8% with semaglutide 2.4 mg versus −3.5% with placebo (estimated treatment difference −8.3%; 95% confidence interval [CI] –10.2, −6.4; p < 0.0001). At Week 44, a greater proportion of participants treated with semaglutide 2.4 mg achieved ≥5% body weight loss versus placebo (85.4% vs. 26.8%): odds ratio 16.1; 95% CI 8.4, 30.9; p < 0.0001. Adverse events were reported by 92.3% of semaglutide-treated participants and 82.9% of placebo-treated participants, the most common of which were gastrointestinal disorders (126/195, 64.6% vs. 35/105, 33.3%). Conclusions: These data demonstrate beneficial effects of semaglutide 2.4 mg versus placebo, supporting its use in an adult Chinese population with overweight or obesity.