• 07 Sep 2022
• Admin
• News Article

Innovent begins patient dosing in higher-dose cohort of phase 2 trial of mazdutide in Chinese adults with obesity

Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical company, announces that the first participant has been successfully dosed in the higher-dose cohort of a phase 2 clinical trial of mazdutide (R&D Code: IBI362), a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This randomized, double-blinded, placebo-controlled study (ClinicalTrials.gov, NCT04904913) was designed to evaluate the efficacy and safety of mazdutide in Chinese participants with overweight or obesity. Results for the low dose cohorts (3.0 mg, 4.5 mg and 6.0 mg) were disclosed in June of this year and the primary endpoint was met. At Week 24, each dose of mazdutide showed significant efficacy on body weight loss compared with placebo in a dose-dependent manner and brought multiple cardio-metabolic benefits to participants; meanwhile, mazdutide was well tolerated and the overall safety profile was similar to other drugs of the same class. In addition, mazdutide titrated to 9 mg showed a good safety profile and a 12-week body weight loss of 11.7% in the phase 1b study (ClinicalTrials.gov, NCT04440345). Based on these results, Innovent will further evaluate the efficacy and safety for a higher dose (9.0 mg) mazdutide in Chinese patients with obesity (BMI = 30 kg/m2). A total of 80 participants are planned to be enrolled and will be randomized in a 3:1 ratio to receive mazdutide 9.0 mg or placebo for 24 weeks. The primary endpoint was the percent change from baseline in body weight at Week 24. Professor Linong Ji, the principal investigator of the study, Peking University People