Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese adults. The trial successfully met its primary endpoint and all key secondary endpoints, reinforcing the drug’s potential in glycemic control and additional benefits in weight loss and cardiometabolic health.
The DREAMS-1 trial (NCT05628311), a randomized, double-blind, placebo-controlled study, was designed to evaluate the efficacy and safety of mazdutide in T2D patients with insufficient glycemic control managed through diet and exercise alone. The study involved 320 participants who were randomized to receive either mazdutide 4mg, mazdutide 6mg, or placebo for 24 weeks during the double-blind period. Following this period, participants in the 4mg and 6mg groups continued their treatment, while those in the placebo group were switched to receive mazdutide 6mg for an additional 24 weeks.
At the 24-week mark, both the mazdutide 4mg (1.57%) and 6mg groups (2.15%) demonstrated a superior reduction in HbA1c levels compared to the placebo group (0.14%; both p-values < 0.0001). The efficacy in reducing HbA1c levels was sustained through the 48th week. Mazdutide also showed key secondary benefits in glucose-lowering and weight reduction. Moreover, the drug reduced cardiovascular metabolic indicators such as postprandial blood glucose, waist circumference, blood pressure, blood lipids, transaminases, and urinary albumin-to-creatinine ratio. The overall safety and tolerability profile of mazdutide was favorable and consistent with previous clinical studies, with no new safety signals identified.
Building on the successful DREAMS-1 and DREAMS-2 trials, where mazdutide showed superiority over dulaglutide in glycemic control and demonstrated weight loss and multiple cardiometabolic benefits in T2D patients, Innovent plans to submit a new drug application (NDA) for mazdutide for T2D treatment to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) in the near future. This follows the acceptance of its first NDA for chronic weight management in February 2024.- Flcube.com
