Beinaglutide for weight management in Chinese individuals with overweight or obesity: A phase 3 randomized controlled clinical study.

Autor: Chen, Kang, Chen, Li, Shan, Zhongyan, Wang, Guixia, Qu, Shen, Qin, Guijun, Yu, Xuefeng, Xin, Weiquan, Hsieh, Tsung‐han, Mu, Yiming
Předmět:
Zdroj: Diabetes, Obesity & Metabolism; Feb2024, Vol. 26 Issue 2, p690-698, 9p
Abstrakt: Aim: To investigate the efficacy and safety of beinaglutide as an adjunct to lifestyle intervention among non‐diabetic Chinese individuals with overweight or obesity. Methods: This multicentre, randomized, double‐blind, placebo‐controlled trial (ChiCTR1900023428) included 427 Chinese adults with a body mass index of 28 kg/m2 or higher (obesity) or 24‐27.9 kg/m2 (overweight) with weight‐related complications. Patients were randomized in a 2:1 ratio to receive 0.2 mg of beinaglutide (subcutaneous) thrice daily or placebo for 16 weeks. Co‐primary endpoints were body weight change and the proportion of patients with a weight reduction of 5% or more. Results: Mean body weight change from baseline to week 16 was −6.0% and −2.4% in the beinaglutide (n = 282) and placebo (n = 138) groups, respectively; the mixed model repeated measures difference was −3.6% (95% confidence interval: −4.6% to −2.6%; P <.0001). At week 16, more beinaglutide‐treated patients achieved a weight reduction of 5% or more (58.2% vs. 25.4% [placebo], odds ratio: 4.4; P <.0001) and of 10% or more (21.3% vs. 5.1% [placebo], odds ratio: 5.5; P <.0001). Beinaglutide also resulted in greater waist circumference reduction (difference: −1.81 cm; P <.01). The weight regain rate 12 weeks after beinaglutide treatment was 0.78%. Nausea (transient and mild‐to‐moderate) was the most common adverse event in the beinaglutide group (49.3% vs. 7.1% [placebo]). More patients receiving beinaglutide discontinued treatment because of adverse events (5.9% vs. 0.7% [placebo]). Pancreatitis or an increased resting heart rate was not observed in the beinaglutide group. Conclusion: Beinaglutide combined with lifestyle intervention resulted in significant and clinically meaningful weight reduction with good tolerance in non‐diabetic Chinese individuals with overweight or obesity. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index