作者
Yijun Li,Zhifeng Cheng,Weiping Lu,Ping Li,Hongwei� Jiang,Jing Yang,Jing Xu,Cheng Zhang,Lili Zhang,Yao Wang,Fang Bian,Weiying Guo,Xuefeng Yu,Xiaopan Chen,Dong Zhao,Bo Feng,Shen Qu,Jie Qin,Yifei Zhang,Lin Wang,Hao Chen,Yiming Mu
摘要
Abstract Aim To evaluate the effect of noiiglutide as an adjunct to lifestyle intervention on the reduction in body weight and tolerability in obese Chinese adults without diabetes. Materials and Methods In this 24‐week, randomized, double‐blind, placebo‐controlled phase 2 trial, 254 obese adults with a body mass index of 28.0‐40.0 kg/m 2 and without diabetes were enrolled. Participants were initially randomized in a 1:1:1 ratio to one of three dose levels: 0.12, 0.24, or 0.36 mg of the study treatment. Within each dose level, participants were further randomized in a 3:1 ratio to receive either subcutaneous injection of noiiglutide or a matching placebo. The primary endpoint was the change in body weight from baseline to week 24. Results Across all noiiglutide dosage levels, least squares mean reductions in body weight from baseline to week 24 ranged from 8.03 to 8.50 kg, compared with 3.65 kg in the placebo group (all p ‐values <.0001). In the noiiglutide groups (0.12, 0.24, 0.36 mg/day), a significantly higher proportion of participants achieved a weight loss ≥5% (68.8%, 60.0%, 73.0%) and ≥10% (37.5%, 36.9%, 39.7%), compared with the pooled placebo group (≥5%: 29.0%; ≥10%: 8.1%). Gastrointestinal adverse events, such as nausea, diarrhoea and vomiting, were more common in all noiiglutide groups (15.4%‐30.2%, 18.8%‐22.2%, 15.6%‐18.5%) than in the pooled placebo group (8.1%, 6.5%, 0%). Conclusions In obese Chinese adults without diabetes, once‐daily subcutaneous noiiglutide significantly reduced body week at week 24 compared with placebo, and had a manageable safety profile, primarily involving gastrointestinal disorders.