Core Insights - Innovent Biologics has presented the results of the Phase 3 clinical trial of mazdutide, demonstrating its efficacy in weight loss and reduction of cardiometabolic risk factors in adults with obesity or overweight [1][2][3] Group 1: Clinical Trial Results - The GLORY-1 trial met all primary and key secondary endpoints, confirming the advantages of mazdutide as a GLP-1R/GCGR dual agonist [1][3] - At week 48, participants receiving mazdutide 6 mg experienced a mean percentage weight change of -14.31% compared to placebo [3][4] - Significant weight loss was observed, with 82.0% of participants on mazdutide 6 mg achieving a weight reduction of 5% or more at week 32 [4][5] Group 2: Cardiometabolic Benefits - Mazdutide treatment resulted in significant reductions in waist circumference and multiple cardiometabolic risk factors, including systolic blood pressure and triglycerides [6][7] - At week 48, the pooled mazdutide group showed a reduction in liver fat content by an average of 80.2% in participants with high baseline liver fat [7] Group 3: Safety and Tolerability - The safety profile of mazdutide was favorable, with a low incidence of serious adverse events comparable to placebo [7] - Common adverse events were mostly mild or moderate gastrointestinal issues, with no new safety signals identified [7] Group 4: Regulatory and Market Potential - The first new drug application (NDA) for mazdutide is currently under review by the CDE of the National Medical Products Administration (NMPA) in China [2][12] - If approved, mazdutide is expected to provide a safe and effective treatment option for obesity, addressing a significant unmet clinical need in the Chinese market [10][11]
Innovent Presents the Results of the First Phase 3 Study of Mazdutide for Weight Management at the ADA's 84th Scientific Sessions