Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company, announced on Sunday that it has met the primary endpoint and all key secondary endpoints in the second phase three clinical trial (DREAMS-1) of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with type 2 diabetes (T2D).

Another Phase 3 clinical trial DREAMS-2 has previously met the study endpoints, in which mazdutide showed superiority compared with dulaglutide for glycaemic control, as well as weight loss and multiple cardiometabolic benefits in T2D patients.

Innovent plans to submit a new drug application (NDA) of mazdutide for T2D treatment to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term, following the acceptance of its first NDA for chronic weight management in February 2024.

DREAMS-1 (NCT05628311) is a randomised, double-blind, placebo-controlled, Phase 3 clinical trial designed to evaluate the efficacy and safety of mazdutide in Chinese adults with T2D and insufficient glycaemic control using diet and exercise alone. A total of 320 participants were enrolled in the study (mean HbA1c and body weight at baseline were 8.24% and 77.7kg, respectively) and randomized in a 1: 1: 1 ratio to receive either mazdutide 4mg, mazdutide 6mg or placebo for 24 weeks in the double-blind period; after completing the double-blind treatment period, participants in the 4mg and 6mg groups maintained receiving treatment, while those in the placebo group were switched to receive mazdutide 6mg for 24 weeks. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) at week 24; a superiority design was used to test the superiority of each dose group of mazdutide versus placebo for the primary endpoint and key secondary endpoints.

The primary endpoint was successfully met, showing a robust glucose-lowering efficacy of mazdutide.