Efficacy and safety of once-weekly semaglutide 2·4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial.

This trial aimed to evaluate the efficacy, tolerability, and safety of semaglutide 2·4 mg in adults from mainland China and Taiwan with overweight or obesity according to locally defined, BMI thresholds.

本试验旨在评估在中国大陆和台湾的成人中，根据当地定义的 BMI 阈值，Semaglutide 2·4 mg 对超重或肥胖的疗效、耐受性和安全性。

Methods

This completed randomised, double-blind, placebo-controlled, multicentre, two-armed, parallel-group, phase 3b trial (STEP 12) was conducted at 19 sites across mainland China and Taiwan.

这项已完成的随机、双盲、安慰剂对照、多中心、两臂、平行组、3b 期试验（STEP 12）在中国大陆和台湾的 19 个地点进行。

Adults with a BMI of 24-<28 kg/m2 and at least one weight-related comorbidity, or a BMI of 28-<30 kg/m2, with or without type 2 diabetes, were randomly assigned (2:1) to once-weekly subcutaneous semaglutide 2·4 mg or placebo, plus lifestyle intervention, for 44 weeks.

随机分配（2:1）每周一次皮下注射 Semaglutide 2·4 mg 或安慰剂，加上生活方式干预，为期 44 周，对象为 BMI 为 24-<28 kg/m2 且至少有一种与体重相关的合并症，或 BMI 为 28-<30 kg/m2，无论是否伴有 2 型糖尿病的成人。

Randomisation was performed by the study sponsor using the Randomisation Trial Supplies Management System.

随机化是由研究赞助商使用随机试验供应管理系统进行的。

Coprimary endpoints were percentage change in bodyweight and the proportion of participants achieving at least 5% bodyweight reduction.

共同主要终点是体重的百分比变化和至少减轻 5% 体重的参与者的比例。

Safety was analysed descriptively in all participants who received the trial intervention.

在所有接受试验干预的参与者中描述性地分析了安全性。

Missing data at week 44 were imputed with washout multiple imputation.

在第 44 周时缺失的数据通过洗脱多重插补法进行估算。

This study is registered with ClinicalTrials.gov, NCT06041217, and is completed.

该研究已在ClinicalTrials.gov注册，编号为NCT06041217，并已完成。

Results

Between Sept 15, 2023, and May 7, 2025, of 254 screened participants, 161 (66·5%) of 242 participants were randomly assigned to semaglutide 2·4 mg and 81 (33·5%) to placebo; 121 (50·0%) participants were female, and 47 (19·4%) participants had type 2 diabetes.

在2023年9月15日至2025年5月7日期间，从254名筛选的参与者中，有161名（占242名参与者的66.5%）被随机分配到2.4毫克的semaglutide组，81名（占33.5%）被分配到安慰剂组；121名（占50.0%）参与者为女性，47名（占19.4%）参与者患有2型糖尿病。

Bodyweight reduction was greater with semaglutide versus placebo (-12·1% [SE 0·6] vs -2·2% [0·8]; estimated treatment difference -9·9 percentage points [95% CI -11·8 to -8·0]; p<0·0001), with a greater proportion of participants achieving at least 5% bodyweight reduction (80·5% vs 24·4%; odds ratio [OR] 14·8 [95% CI 7·4 to 29·6]; p<0·0001).

与安慰剂相比，semaglutide组的体重减少更多（-12.1% [SE 0.6] 对比 -2.2% [0.8]；估计的治疗差异为-9.9个百分点 [95% CI -11.8 到 -8.0]；p<0.0001），并且有更大比例的参与者实现了至少5%的体重减少（80.5% 对比 24.4%；优势比 [OR] 14.8 [95% CI 7.4 到 29.6]；p<0.0001）。

Adverse events were reported in 141 (87·6%) of 161 participants in the semaglutide 2·4 mg group and 61 (75·3%) of 81 participants in the placebo group, with gastrointestinal disorders being the most common.

在2.4毫克semaglutide组的161名参与者中，有141名（占87.6%）报告了不良事件，在81名安慰剂组参与者中，有61名（占75.3%）报告了不良事件，其中胃肠疾病是最常见的。

interpretation

Semaglutide 2·4 mg provided a superior reduction in bodyweight versus placebo in Chinese adults with overweight or obesity.

在超重或肥胖的中国成人中，2.4毫克semaglutide与安慰剂相比提供了更优越的体重减少效果。

The safety profile was consistent with the known profile of semaglutide.

安全性特征与semaglutide已知的特征一致。

funding

Novo Nordisk A/S.

诺和诺德公司。

translation

For the Mandarin translation of the abstract see Supplementary Materials section.

摘要的中文翻译请参见补充材料部分。