Introduction and Objective: To evaluate the efficacy and safety of mazdutide 6 mg vs semaglutide 1 mg in Chinese T2D patients (pts) with obesity who had inadequately glycaemic control and suboptimal weight loss (WL) following lifestyle interventions with or without metformin (NCT06184568). Methods: A total of 349 pts aged ≥18 years with T2D duration ≤10 years who had a BMI of ≥28 kg/m2 and HbA1c 7.0% to 10.5% at screening were randomly assigned in a 1:1 ratio to receive subcutaneous mazdutide 6 mg or semaglutide 1 mg. The primary endpoint was the proportion of pts achieving both HbA1c7.0% and WL ≥10% at week 32. Results: At baseline, the mean HbA1c was 8.02% and mean BMI was 33.0 kg/m2. Mazdutide 6 mg was superior to semaglutide 1 mg with respect to the primary endpoint, demonstrating significantly greater reductions in HbA1c and weight, as well as improvements on cardiometabolic risk factors (Table). The most common adverse events were gastrointestinal (GIAEs), including nausea (30.5% with mazdutide; 12.6% with semaglutide), diarrhoea (27.0%; 21.8%), and vomiting (23.6%; 8.6%), and mostly mild to moderate in severity. Conclusion: Mazdutide 6 mg demonstrated superior dual metabolic efficacy vs semaglutide 1 mg in Chinese pts with early-stage T2D and comorbid obesity. Although GIAEs were more frequent with mazdutide 6 mg, its overall safety profile was manageable. Disclosure Y. Luo: None. H. Jiang: Consultant; Current; Innovent Biologics. B. Shi: None. H. Cai: None. H. Wang: None. W. Qiu: None. S. Li: None. R. Zhou: Employee; Current; Innovent Biologics, Inc. L. Li: Employee; Current; Innovent Biologics, Inc. H. Du: Employee; Current; Innovent Biologics. Employee; Ended; Burning Rock Biotech. H. Han-Zhang: None. H. Deng: Employee; Current; Innovent Biologics, Inc. L. Qian: Employee; Current; Innovent Biologics, Inc. L. Ji: None. Funding Innovent Biologics
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