The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Qilu Hospital of Shandong University, Jinan, China.
Diabetes Obes Metab. 2024 Feb;26(2):690-698. doi: 10.1111/dom.15360. Epub 2023 Nov 9.
To investigate the efficacy and safety of beinaglutide as an adjunct to lifestyle intervention among non-diabetic Chinese individuals with overweight or obesity.
This multicentre, randomized, double-blind, placebo-controlled trial (ChiCTR1900023428) included 427 Chinese adults with a body mass index of 28 kg/m or higher (obesity) or 24-27.9 kg/m (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.
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.
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.
评估贝那鲁肽联合生活方式干预在超重或肥胖的非糖尿病中国人群中的疗效和安全性。
这是一项多中心、随机、双盲、安慰剂对照试验（ChiCTR1900023428），纳入了 427 名中国成年人，其体重指数（BMI）为 28kg/m²或更高（肥胖）或 24-27.9kg/m²（超重）且伴有与体重相关的并发症。患者以 2:1 的比例随机接受 0.2mg 贝那鲁肽（皮下注射）每日三次或安慰剂治疗 16 周。主要疗效终点为体重变化和体重减轻 5%或更多的患者比例。
贝那鲁肽（n=282）和安慰剂（n=138）组治疗 16 周后，自基线的平均体重变化分别为-6.0%和-2.4%；混合模型重复测量差值为-3.6%（95%置信区间：-4.6%至-2.6%；P<0.0001）。第 16 周时，更多的贝那鲁肽治疗患者达到体重减轻 5%或更多（58.2%比 25.4%[安慰剂]，比值比：4.4；P<0.0001）和 10%或更多（21.3%比 5.1%[安慰剂]，比值比：5.5；P<0.0001）。贝那鲁肽还导致腰围减少（差值：-1.81cm；P<0.01）。贝那鲁肽治疗 12 周后体重回升率为 0.78%。贝那鲁肽组（49.3%比 7.1%[安慰剂]）最常见的不良事件为短暂性和轻中度恶心。更多接受贝那鲁肽治疗的患者因不良事件而停止治疗（5.9%比 0.7%[安慰剂]）。贝那鲁肽组未观察到胰腺炎或静息心率增加。
贝那鲁肽联合生活方式干预可显著且具有临床意义地减轻非糖尿病中国超重或肥胖人群的体重，且具有良好的耐受性。
