Chinese biopharmaceutical company Innovent Biologics Inc (HKEX: 01801) announced on Wednesday 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) for mazdutide 9 mg for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) soon.

GLORY-2, a Phase 3 clinical study, was designed to evaluate the efficacy and safety of mazdutide 9 mg integrated with lifestyle intervention compared to placebo in Chinese adults with obesity (BMI greater than or equal to 30 kg/m2).

The study enrolled 462 people, including 16% with type 2 diabetes. Participants were randomised in a 2:1 ratio to receive mazdutide 9 mg or placebo in the 60-week double-blind treatment period (mean baseline weight: 94.0 kg; mean BMI: 34.3 kg/m2).

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. 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 (placebo: 2.81%), with 48.7% of participants achieving a weight reduction of 20% or more (placebo: 3.1%. Other secondary endpoints of the study that were met included other body weight endpoints, waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid levels.