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

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...

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Published in:Nature communications 2023-12, Vol.14 (1), p.8289-10, Article 8289
Main Authors: Ji, Linong, Jiang, Hongwei, Cheng, Zhifeng, Qiu, Wei, Liao, Lin, Zhang, Yawei, Li, Xiaoli, Pang, Shuguang, Zhang, Lihui, Chen, Liming, Yang, Tao, Li, Yan, Qu, Shen, Wen, Jie, Gu, Jieyu, Deng, Huan, Wang, Yanqi, Li, Li, Han-Zhang, Han, Ma, Qingyang, Qian, Lei
Format: Article
Language:English
Subjects:
692/163/2743/2037
692/163/2743/393
692/308/153
Adults
Agonists
Body weight
Body weight loss
Comorbidity
Diarrhea
Glucagon
Glucagon-like peptide 1
Humanities and Social Sciences
Hyperphagia
multidisciplinary
Obesity
Overweight
Peptides
Placebos
Receptors
Respiratory tract
Respiratory tract infection
Science
Science (multidisciplinary)
Weight control
Weight loss
Weight reduction
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Summary: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/m 2 ) accompanied by hyperphagia and/or at least one obesity-related comorbidity or adults with obesity (BMI ≥ 28 kg/m 2 ) 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  
ISSN:2041-1723
2041-1723
DOI:10.1038/s41467-023-44067-4