A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity

Linong Ji (), Hongwei Jiang, Zhifeng Cheng, Wei Qiu, Lin Liao, Yawei Zhang, Xiaoli Li, Shuguang Pang, Lihui Zhang, Liming Chen, Tao Yang, Yan Li, Shen Qu, Jie Wen, Jieyu Gu, Huan Deng, Yanqi Wang, Li Li, Han Han-Zhang, Qingyang Ma and Lei Qian ()
Additional contact information
Linong Ji: Peking University People’s Hospital
Hongwei Jiang: Henan University of Science and Technology
Zhifeng Cheng: The Fourth Affiliated Hospital of Harbin Medical University
Wei Qiu: Huzhou Central Hospital
Lin Liao: Shandong Province Qianfoshan Hospital
Yawei Zhang: Pingxiang People’s Hospital
Xiaoli Li: The First Affiliated Hospital of Bengbu Medical College
Shuguang Pang: Jinan Central Hospital
Lihui Zhang: The Second Hospital of Hebei Medical University
Liming Chen: Tianjin Medical University
Tao Yang: Jiangsu Province Hospital
Yan Li: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Shen Qu: Shanghai Tenth People’s Hospital of Tong Ji University
Jie Wen: Innovent Biologics, Inc.
Jieyu Gu: Innovent Biologics, Inc.
Huan Deng: Innovent Biologics, Inc.
Yanqi Wang: Innovent Biologics, Inc.
Li Li: Innovent Biologics, Inc.
Han Han-Zhang: Innovent Biologics, Inc.
Qingyang Ma: Innovent Biologics, Inc.
Lei Qian: Innovent Biologics, Inc.

Nature Communications, 2023, vol. 14, issue 1, 1-10

Abstract: Abstract Mazdutide is a once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. We evaluated the efficacy and safety of 24-week treatment of mazdutide up to 6 mg in Chinese overweight adults or adults with obesity, as an interim analysis of a randomised, two-part (low doses up to 6 mg and high dose of 9 mg), double-blind, placebo-controlled phase 2 trial (ClinicalTrials.gov, NCT04904913). Overweight adults (body-mass index [BMI] ≥24 kg/m2) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m2) were randomly assigned (3:1:3:1:3:1) to once-weekly mazdutide 3 mg, 4.5 mg, 6 mg or matching placebo at 20 hospitals in China. The primary endpoint was the percentage change from baseline to week 24 in body weight. A total of 248 participants were randomised to mazdutide 3 mg (n = 62), 4.5 mg (n = 63), 6 mg (n = 61) or placebo (n = 62). The mean percentage changes from baseline to week 24 in body weight were −6.7% (SE 0.7) with mazdutide 3 mg, −10.4% (0.7) with 4.5 mg, −11.3% (0.7) with 6 mg and 1.0% (0.7) with placebo, with treatment difference versus placebo ranging from −7.7% to −12.3% (all p

Date: 2023
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DOI: 10.1038/s41467-023-44067-4

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