INDIANAPOLIS (dpa-AFX) - Innovent Biologics, Inc. (IVBXF, 1801.HK) announced that the Phase 3 clinical trial of mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese adults with obesity (GLORY-2) met the primary endpoints and all key secondary endpoints.
Innovent plans to submit the new drug application (NDA) of mazdutide 9 mg for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term.
During the treatment period, participants in the mazdutide group exhibited continuous weight loss, with no plateau observed in Week 60. At Week 60, the mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group. 44.0% of participants in the mazdutide 9 mg group achieved a weight reduction of 20% or more, versus 2.6% in the placebo group.
According to the company, the key secondary endpoints demonstrated that among participants without type 2 diabetes, the mazdutide 9 mg group showed a mean weight reduction of 20.08% at Week 60, with 48.7% of participants achieving a weight reduction of 20% or more (placebo: 3.1%; P<0.0001).
Furthermore, all key secondary endpoints of the study were met, including other body weight endpoints, waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid levels. Mazdutide 9 mg demonstrated superiority to placebo in all the above weight-loss and cardiometabolic endpoints.
The study also evaluated liver fat content using MRI-PDFF in a subset of participants. Among participants (without type 2 diabetes) with baseline liver fat content ?10%, the mean percent change in liver fat content from baseline to week 60 was -71.9% in the mazdutide 9 mg group compared with 5.1% in the placebo group.
The company stated that the Mazdutide 9 mg demonstrated favorable tolerability and safety profiles, with no new safety signals identified. The majority of gastrointestinal adverse events were mild to moderate in severity and transient in nature. The proportion of participants who discontinued treatment prematurely due to adverse events was 2.9% in the mazdutide 9 mg group and 0% in the placebo group.
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