Innovent's Phase 3 Trial of Mazdutide for Type 2 Diabetes in China Meets Endpoints, NDA Submission Planned

Innovent Biologics, Inc. (Innovent), a renowned biopharmaceutical company, has announced that its Phase 3 clinical trial (DREAMS-1) for mazdutide (IBI362), a dual agonist of glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR), successfully met both primary and key secondary endpoints in Chinese adults with type 2 diabetes (T2D). This announcement follows the success of another Phase 3 trial, DREAMS-2, which demonstrated mazdutide's superiority over dulaglutide in managing glycemic levels, weight, and other cardiometabolic parameters in T2D patients. Innovent is preparing to submit a new drug application (NDA) for mazdutide for T2D treatment to China's Center for Drug Evaluation (CDE) soon.

The DREAMS-1 trial (NCT05628311) was a randomized, double-blind, placebo-controlled study aimed at assessing the efficacy and safety of mazdutide in Chinese adults whose glycemic levels were inadequately controlled by diet and exercise alone. The trial enrolled 320 participants with a mean baseline HbA1c of 8.24% and mean body weight of 77.7 kg. Participants were randomly assigned to receive either a 4 mg or 6 mg dose of mazdutide, or a placebo, over a 24-week double-blind period. Post this period, those on the placebo were switched to a 6 mg dose of mazdutide for an additional 24 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at week 24.

At week 24, both the 4 mg and 6 mg mazdutide groups showed significant reductions in HbA1c (1.57% and 2.15% respectively) compared to the placebo group (0.14%), with p-values less than 0.0001. This glucose-lowering efficacy was maintained up to week 48. Additionally, the secondary endpoints revealed that mazdutide significantly reduced body weight compared with placebo. At week 48, the 6 mg mazdutide group exhibited a 9.6% reduction in body weight from baseline.

Mazdutide also demonstrated multiple health benefits beyond glucose and weight reduction. It improved cardiovascular metabolic indicators such as postprandial blood glucose, waist circumference, blood pressure, blood lipids, liver enzymes, and urinary albumin-to-creatinine ratio. The safety profile of mazdutide was favorable, with adverse events primarily being mild to moderate gastrointestinal issues. No new safety concerns were identified, and the incidence of hypoglycemia was low, with no severe cases reported.

Professor Dalong Zhu from Nanjing University highlighted the multifaceted benefits of mazdutide in managing T2D, emphasizing its positive effects on blood glucose, weight, lipids, and blood pressure. Professor Jiajun Zhao from Shandong Provincial Hospital underscored the urgent need for innovative medications in China, which has the highest prevalence of diabetes globally. Both professors expressed optimism about mazdutide’s potential to become a superior treatment option for Chinese T2D patients.

Dr. Lei Qian, Innovent's Vice President of Clinical Development, noted that mazdutide is the world's first and fastest-developed GLP-1R/GCGR dual agonist. The DREAMS-1 trial provided compelling evidence of its efficacy for T2D treatment in China, particularly for patients inadequately controlled by diet and exercise. Results from the DREAMS-2 trial further supported mazdutide's effectiveness in patients inadequately controlled by oral antidiabetic drugs, showcasing its comprehensive benefits in glycemic control and metabolic outcomes. Detailed data will be presented at academic forums, and further studies, including the DREAMS-3 trial comparing mazdutide with semaglutide, are anticipated.

Mazdutide, licensed by Innovent from Eli Lilly and Company for development and potential commercialization in China, is a GLP-1R and GCGR dual agonist. It promotes insulin secretion, lowers blood glucose, reduces body weight, and offers additional cardiometabolic benefits. Innovent’s clinical program also includes five Phase 3 studies, three of which—GLORY-1, DREAMS-1, and DREAMS-2—have met their endpoints.

Innovent, founded in 2011, aims to provide affordable, high-quality biopharmaceuticals worldwide. The company has a robust pipeline of products targeting various diseases, including cancer, cardiovascular and metabolic disorders, autoimmune diseases, and eye conditions. Innovent collaborates with global healthcare leaders to advance biopharmaceutical innovation and accessibility.

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