SCI

15 June 2024

Tirzepatide for Weight Reduction in Chinese Adults With Obesity-The SURMOUNT-CN Randomized Clinical Trial

(JAMA, IF: 120.7)

  • Lin Zhao, MD; Zhifeng Cheng, MD; Yibing Lu, MD; Ming Liu, MD; Hong Chen, MD; Min Zhang, MD; RuiWang, MD; Yuan Yuan, PhD; Xiaoying Li, MD

  • CORRESPONDENCE TO: li.xiaoying@zs-hospital.sh.cn

IMPORTANCE 重要性

Obesity has become a global public health concern and China has the largest number of affected people worldwide.

肥胖已成为全球公共卫生问题，中国是全球受影响人数最多的国家。

 

OBJECTIVE 目标

To assess the efficacy and safety of treatment with tirzepatide for weight reduction in Chinese adults with obesity or overweight and weight-related comorbidities.

评估Tirzepatide治疗肥胖或超重以及与体重相关的合并症的中国成年人减肥的有效性和安全性。

 

DESIGN, SETTING, AND PARTICIPANTS 设计、设置和参与者

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.

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29个中心进行，包括体重指数（BMI）大于或等于28的患者，以及体重指数大于或等于24的中国成年人（18岁）并且罹患至少1种与体重相关的合并症的患者，不包括糖尿病。

 

INTERVENTIONS 干预措施

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.

参与者被随机分配（1:1:1），每周接受一次皮下注射10 mg（n=70）或15 mg（n=71）Tirzepatid或安慰剂（n=69）治疗，外加生活方式干预，持续52周。

 

MAIN OUTCOMES AND MEASURES 主要成果和措施

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.

共同的主要终点是体重与基线相比的百分比变化，以及在第52周体重至少减少5%。对意向治疗人群进行疗效和安全性分析。

 

RESULTS 结果

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 10mg, −17.5% (95%CI, −19.7%to −15.3%) with tirzepatide 15mg, and −2.3% with placebo (difference between 10mg and placebo, −11.3%[95%CI, −14.3%to −8.3%; P < .001]; difference between 15mg 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 10mg, 85.8% with tirzepatide 15mg, 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%).

在210名随机参与者中（103名[49.0%]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人（95.7%）完成了试验。第52周时，Tirzepatid 10mg组的平均体重变化为−13.6%（95%CI，−15.8%至−11.4%），Tirzepatid 15mg组为−17.5%（95%CI，−19.7%至−15.3%），安慰剂组为−2.3%（10mg与安慰剂组的差异为−11.3% [95%CI，−14.3%至−8.3%；P<.001]；Tirzepatid  15mg组与安慰剂组之间的差异为–15.1% [95%可信区间，−18.2%至−12.1%；P<.001]）。Tirzepatid 10mg组、Tirzepatid 15mg组和安慰剂组的受试者体重减轻5%或以上的人数百分比分别为87.7%、85.8%和29.3%（与安慰剂组相比，P＜0.001）。Tirzepatid最常见的治疗突发不良事件是胃肠道反应。大多数患者的严重程度为轻度至中度，很少有事件导致治疗中断（<5%）。

 

CONCLUSIONS AND RELEVANCE 结论和相关性

In Chinese adults with obesity or overweight, once-weekly treatment with tirzepatide 10mg or 15mg resulted in statistically significant and clinically meaningful weight reduction with an acceptable safety profile.

在患有肥胖或超重的中国成年人中，每周一次10mg或15mg的Tirzepatid治疗可显著减轻体重，且具有可接受的安全性。

 

TRIAL REGISTRATION 试验注册

ClinicalTrials.gov Identifier: NCT05024032

ClinicalTrials.gov标识符：NCT05024032