At Week 44, 85.4% of participants treated with 2.4 mg achieved a weight loss of at least 5% compared to 26.8% with placebo.
Mean body weight decreased by 11.8% for those on semaglutide 2.4 mg compared to a 3.5% decrease for those on placebo.
The estimated treatment difference in weight change was 8.3%, with a high statistical significance (p < 0.0001).
Adverse events occurred in 92.3% of participants receiving semaglutide 2.4 mg, primarily gastrointestinal disorders.
In contrast, 82.9% of participants on placebo reported adverse events, with fewer gastrointestinal issues.
Simplified
AIM: To evaluate the efficacy and safety of 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.
Key numbers
-11.8%
Mean Body Weight Reduction
Change from baseline to Week 44 with vs. placebo.
85.4%
Proportion Achieving ≥5% Weight Loss
Compared to 26.8% for placebo at Week 44.
92.3%
Adverse Events Reported
Compared to 82.9% in the placebo group.
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Dongmei Lui, Ning Zu and Zewei Shen are employees of Novo Nordisk and own Novo Nordisk stock. Yiming Mu has received speaker honorarium or consultancy fees in advisory boards from Eli Lilly, Novo Nordisk and Sanofi. Weijun Gu, Yibing Lu, Xinhua Ye and Guoyue Yuan have no conflicts of interest to disclose.
