Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Endocrinology, Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.
JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217.
IMPORTANCE: Obesity has become a global public health concern and China has the largest number of affected people worldwide. OBJECTIVE: To assess the efficacy and safety of treatment with tirzepatide for weight reduction in Chinese adults with obesity or overweight and weight-related comorbidities. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 29 centers in China from September 2021 to December 2022 included Chinese adults (aged ≥18 years) with a body mass index (BMI) greater than or equal to 28 or greater than or equal to 24 and at least 1 weight-related comorbidity, excluding diabetes. INTERVENTIONS: Participants were randomly assigned (1:1:1) to receive once-weekly, subcutaneous 10-mg (n = 70) or 15-mg (n = 71) tirzepatide or placebo (n = 69), plus a lifestyle intervention, for 52 weeks. MAIN OUTCOMES AND MEASURES: Co-primary end points were the percent change in body weight from baseline and weight reduction of at least 5% at week 52. Efficacy and safety analyses were performed on an intention-to-treat population. RESULTS: Of 210 randomized participants (103 [49.0%] female; mean [SD] age, 36.1 [9.1] years; body weight, 91.8 [16.0] kg; BMI, 32.3 [3.8]), 201 (95.7%) completed the trial. The mean change in body weight at week 52 was -13.6% (95% CI, -15.8% to -11.4%) with tirzepatide 10 mg, -17.5% (95% CI, -19.7% to -15.3%) with tirzepatide 15 mg, and -2.3% with placebo (difference between 10 mg and placebo, -11.3% [95% CI, -14.3% to -8.3%; P < .001]; difference between 15 mg and placebo, -15.1% [95% CI, -18.2% to -12.1%; P < .001]). The percentage of participants achieving body weight reductions of 5% or greater was 87.7% with tirzepatide 10 mg, 85.8% with tirzepatide 15 mg, and 29.3% with placebo (P < .001 for comparisons with placebo). The most frequent treatment-emergent adverse events with tirzepatide were gastrointestinal. Most were mild to moderate in severity, with few events leading to treatment discontinuation (<5%). CONCLUSIONS AND RELEVANCE: In Chinese adults with obesity or overweight, once-weekly treatment with tirzepatide 10 mg or 15 mg resulted in statistically significant and clinically meaningful weight reduction with an acceptable safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05024032.
重要性：肥胖已成为全球公共卫生关注的问题，而中国是全球肥胖人口最多的国家。
目的：评估替西帕肽治疗中国肥胖或超重合并体重相关合并症成人患者的减重效果和安全性。
设计、地点和参与者：这是一项在中国 29 个中心进行的随机、双盲、安慰剂对照、3 期临床试验，纳入了 2021 年 9 月至 2022 年 12 月期间年龄≥18 岁的中国成年人（BMI≥28 或≥24 且至少有 1 项体重相关合并症，不包括糖尿病）。
干预措施：参与者被随机分配（1:1:1）接受每周 1 次皮下注射 10mg（n=70）或 15mg（n=71）替西帕肽或安慰剂（n=69），同时进行生活方式干预，持续 52 周。
主要终点和测量指标：主要终点是自基线的体重变化百分比和第 52 周体重减轻至少 5%。疗效和安全性分析基于意向治疗人群进行。
结果：210 名随机参与者（103 名[49.0%]为女性；平均[SD]年龄 36.1[9.1]岁；体重 91.8[16.0]kg；BMI 32.3[3.8]），201 名（95.7%）完成了试验。第 52 周时，替西帕肽 10mg组体重减轻了-13.6%（95%CI，-15.8%至-11.4%），替西帕肽 15mg组体重减轻了-17.5%（95%CI，-19.7%至-15.3%），安慰剂组体重减轻了-2.3%（替西帕肽 10mg 与安慰剂组之间的差异为-11.3%[95%CI，-14.3%至-8.3%；P<0.001]；替西帕肽 15mg 与安慰剂组之间的差异为-15.1%[95%CI，-18.2%至-12.1%；P<0.001]）。替西帕肽 10mg 组体重减轻 5%或更多的参与者比例为 87.7%，替西帕肽 15mg 组为 85.8%，安慰剂组为 29.3%（与安慰剂组相比，均 P<0.001）。替西帕肽最常见的治疗相关不良事件为胃肠道事件。大多数不良事件为轻至中度，极少数事件导致治疗中止（<5%）。
结论和相关性：在中国肥胖或超重的成年人中，每周一次的替西帕肽 10mg 或 15mg 治疗可显著减轻体重，具有临床意义，安全性可接受。
试验注册：ClinicalTrials.gov 标识符：NCT05024032。
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