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Efficacy and safety of mazdutide in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled phase 2 trial

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posted on 2023-11-09, 16:08 authored by Bo Zhang, Zhifeng Cheng, Ji Chen, Xin Zhang, Dexue Liu, Hongwei Jiang, Guoqing Ma, Xiaoyun Wang, Shenglian Gan, Juan Sun, Ping Jin, Jianjun Yi, Bimin Shi, Jianhua Ma, Shandong Ye, Guixia Wang, Linong Ji, Xuejiang Gu, Ting Yu, Pei An, Huan Deng, Haoyu Li, Li Li, Qingyang Ma, Lei Qian, Wenying Yang

OBJECTIVE We conducted a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the efficacy and safety of mazdutide, a once-weekly GLP-1 and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Adults with type 2 diabetes inadequately controlled with diet and exercise alone or with stable metformin (glycated haemoglobin A1c [HbA1c] of 7.0%–10.5% [53–91 mmol/mol]) were randomized to receive mazdutide 3 mg (n = 51), mazdutide 4.5 mg (n = 49), mazdutide 6 mg (n = 49), open-label dulaglutide 1.5 mg (n = 50) or placebo (n = 51) subcutaneously for 20 weeks. The primary outcome was change from baseline to week 20 in HbA1c. RESULTS Mean changes in HbA1c from baseline to week 20 ranged from −1.41% to −1.67% with mazdutide (−1.35% with dulaglutide and 0.03% with placebo) (all p<0.0001 versus placebo). Mean percent changes in body weight from baseline to week 20 were dose-dependent and up to −7.1% with mazdutide (−2.7% with dulaglutide and −1.4% with placebo). At week 20, participants with mazdutide were more likely to achieve HbA1c target of <7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol), and body weight loss from baseline of ≥5% and ≥10%, compared with placebo-treated. The most common adverse events with mazdutide included diarrhoea (36%), decreased appetite (29%), nausea (23%), vomiting (14%) and hypoglycemia (10%; 8% with placebo). CONCLUSIONS In Chinese patients with type 2 diabetes, mazdutide dosed up to 6 mg was generally safe and demonstrated clinically meaningful HbA1c and body weight reduction. Article Highlights l Despite increasing application of GLP-1 receptor agonists in glycemic control, evidence of co-agonism with glucagon receptor in the treatment of type 2 diabetes remains limited. l Does mazdutide, a once-weekly GLP-1 and glucagon receptor dual agonist, reduce HbA1c and body weight in patients with type 2 diabetes? l In this phase 2 study, 20 weeks’ treatment with mazdutide achieved mean HbA1c reductions up to 1.67% and mean body weight reductions up to 7.1%. The most common adverse events with mazdutide were gastrointestinal in nature. l The results supported future development of mazdutide for the treatment of type 2 diabetes.

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