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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.9217

摘要内容如下：

重要性

肥胖已成为全球关注的公共健康问题，中国是世界上受影响人数最多的国家。

目的

评估中国成人肥胖或超重及体重相关合并症患者使用Tirzepatide治疗减肥的有效性和安全性。

设计、设置和参与者

这项随机、双盲、安慰剂对照的3期临床试验于2021年9月至2022年12月在中国的29个中心进行，纳入了身体质量指数（BMI）大于或等于28或大于或等于24且至少有1种体重相关合并症（不包括糖尿病）的中国成年人（年龄≥18岁）。

干预措施

参与者被随机分配（1:1:1）接受每周一次的皮下注射10 mg（n=70）或15 mg（n=71）Tirzepatide或安慰剂（n=69），加上生活方式干预，为期52周。

主要成果和措施

共同主要终点是体重相对于基线的百分比变化以及第52周时体重至少减少5%。对意向治疗人群进行疗效和安全性分析。

结果

在210名随机参与者中（103[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（95.7%）完成了试验。第52周时，Tirzepatide 10 mg组的平均体重变化为-13.6%（95%CI，-15.8%至-11.4%），Tirzepatide 15 mg组为-17.5%（95%CI，-19.7%至-15.3%），安慰剂组为-2.3%（10 mg组与安慰剂组之间的差异为-11.3%[95%CI，-14.3%至-8.3%；P<.001]；15 mg和安慰剂之间的差异，-15.1%[95%CI，-18.2%至-12.1%；P<.001]）。Tirzepatide 10 mg组、Tirzepatide 15 mg组和安慰剂组的受试者体重减轻5%或更多的百分比分别为87.7%、85.8%和29.3%（与安慰剂相比，P<.001）。最常见的治疗中出现的不良事件是胃肠道。大多数严重程度为轻度至中度，少数事件导致治疗中断（<5%）。

结论和相关性

在患有肥胖或超重的中国成人中，每周一次的Tirzepatide 10 mg或15 mg治疗导致具有统计学意义和临床意义的体重减轻，并具有可接受的安全性。

试用注册

ClinicalTrials.gov标识符：NCT05024032。

英文原文如下：

Abstracts

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.

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