"Efficacy of noiiglutide injection on body weight in obese Chinese adults without diabetes: A multicentre, randomized, double-blind, placebo-controlled, phase 2 trial"

作者全名："Li, Yijun; Cheng, Zhifeng; Lu, Weiping; Li, Ping; Jiang, Hongwei; Yang, Jing; Xu, Jing; Zhang, Cheng; Zhang, Lili; Wang, Yao; Bian, Fang; Guo, Weiying; Yu, Xuefeng; Chen, Xiaopan; Zhao, Dong; Feng, Bo; Qu, Shen; Qin, Jie; Zhang, Yifei; Wang, Lin; Cheng, Hong; Mu, Yiming"

作者地址："[Mu, Yiming] Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Dept Endocrinol, Beijing 100853, Peoples R China; [Li, Yijun; Mu, Yiming] Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Beijing, Peoples R China; [Cheng, Zhifeng] Harbin Med Univ, Affiliated Hosp 4, Harbin, Peoples R China; [Lu, Weiping] Nanjing Med Univ, Affiliated Huaian 1 Peoples Hosp, Huaian, Peoples R China; [Li, Ping] Yuncheng Cent Hosp Shanxi Prov, Yuncheng, Peoples R China; [Jiang, Hongwei] Henan Univ Sci & Technol, Affiliated Hosp 1, Luoyang, Peoples R China; [Yang, Jing] Shanxi Med Univ, Hosp 1, Taiyuan, Peoples R China; [Xu, Jing] Xi An Jiao Tong Univ, Affiliated Hosp 2, Xian, Peoples R China; [Zhang, Cheng] Chongqing Sanxia Cent Hosp, Chongqing, Peoples R China; [Zhang, Lili] Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China; [Wang, Yao] Southeast Univ, Zhongda Hosp, Nanjing, Peoples R China; [Bian, Fang] Cangzhou Peoples Hosp, Cangzhou, Peoples R China; [Guo, Weiying] First Hosp Jilin Univ, Changchun, Peoples R China; [Yu, Xuefeng] Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China; [Chen, Xiaopan] Hainan Med Coll, Affiliated Hosp 1, Haikou, Peoples R China; [Zhao, Dong] Capital Med Univ, Luhe Hosp, Beijing, Peoples R China; [Feng, Bo] Shanghai East Hosp, Shanghai, Peoples R China; [Qu, Shen] Shanghai Tenth Peoples Hosp, Shanghai, Peoples R China; [Qin, Jie] Shanxi Prov Peoples Hosp, Taiyuan, Peoples R China; [Zhang, Yifei; Wang, Lin; Cheng, Hong] Jiangsu Hengrui Pharmaceut Co Ltd, Shanghai, Peoples R China"

通信作者："Mu, YM (通讯作者)，Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Dept Endocrinol, Beijing 100853, Peoples R China."

来源：DIABETES OBESITY & METABOLISM

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001126597500001

JCR分区：Q1

影响因子：5.4

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：body weight; glucagon-like peptide-1; noiiglutide; obese adults

摘要："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."

基金机构：Jiangsu Hengrui Pharmaceuticals; Jiangsu Hengrui Pharmaceuticals

基金资助正文：Jiangsu Hengrui Pharmaceuticals