SAN FRANCISCO and SUZHOU, China, July 22, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the Phase 3 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) met the primary endpoint and all key secondary endpoints. 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 randomized, double-blind, placebo-controlled, Phase 3 clinical trial designed to evaluate the efficacy and safety of mazdutide in Chinese adults with T2D and insufficient glycemic 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 77.7 kg, respectively) and randomized in a 1: 1: 1 ratio to receive either mazdutide 4 mg, mazdutide 6 mg or placebo for 24 weeks in the double-blind period; after completing the double-blind treatment period, participants in the 4 mg and 6 mg groups maintained receiving treatment, while those in the placebo group were switched to receive mazdutide 6 mg for 24 weeks. The primary endpoint was the change from baseline in glycated hemoglobin (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
At week 24, the reduction from baseline in HbA1c in both the mazdutide 4 mg (1.57%) and 6 mg groups (2.15%) was superior to the placebo (0.14%; both p-values < 0.0001). The efficacy of HbA1c reduction in patients treated with mazdutide was sustained through week 48.
Key secondary endpoints suggest dual advantages of mazdutide in glucose-lowering and weight-reduction
At week 24, mazdutide showed significantly higher weight reduction compared with placebo. The proportion of patients who achieved HbA1c Read The Rest at :
