Gu Weijun, Lu Yibing, Ye Xinhua, Yuan Guoyue, Liu Dongmei, Shen Zewei, Zu Ning, Mu Yiming
Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Diabetes Obes Metab. 2025 May;27(5):2540-2551. doi: 10.1111/dom.16253. Epub 2025 Mar 11.
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.
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.
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%).
These data demonstrate beneficial effects of semaglutide 2.4 mg versus placebo, supporting its use in an adult Chinese population with overweight or obesity.
评估司美格鲁肽2.4毫克与安慰剂相比，在超重或肥胖的中国成年人群体中进行体重管理的疗效和安全性。
在STEP 7（NCT04251156），一项双盲3a期试验中，来自主要为东亚人群的超重或肥胖成年人，无论有无2型糖尿病，均按2:1随机分组，接受每周一次皮下注射司美格鲁肽2.4毫克或安慰剂，为期44周，作为低热量饮食和增加体力活动的辅助措施。这项预先设定的分析评估了STEP 7中的中国参与者。主要终点是从基线到第44周体重的百分比变化，以及体重较基线减轻≥5%的参与者比例。
总体而言，195名中国参与者被随机分配至司美格鲁肽2.4毫克组，105名被分配至安慰剂组。从基线到第44周，司美格鲁肽2.4毫克组的平均体重估计变化为-11.8%，而安慰剂组为-3.5%（估计治疗差异为-8.3%；95%置信区间[CI]-10.2，-6.4；p<0.0001）。在第44周时，接受司美格鲁肽2.4毫克治疗的参与者中体重减轻≥5%的比例高于安慰剂组（85.4%对26.8%）：优势比为16.1；95%CI 8.4，30.9；p<0.0001。司美格鲁肽治疗组92.3%的参与者和安慰剂治疗组82.9%的参与者报告了不良事件，最常见的是胃肠道疾病（126/195，64.6%对35/105，33.3%）。
这些数据表明司美格鲁肽2.4毫克与安慰剂相比具有有益效果，支持其在超重或肥胖的中国成年人群体中的使用。
