Head-to-head Superiority over Dulaglutide: Innovent's Phase 3 Clinical Trial DREAMS-2 of Mazdutide in Chinese Patients with Type 2 Diabetes were Orally Presented at EASD 2024

Core Viewpoint - Innovent Biologics has announced positive Phase 3 clinical trial results for mazdutide, a dual agonist for GLP-1R and GCGR, showing superior efficacy in glycemic control and weight loss compared to dulaglutide in Chinese adults with type 2 diabetes [1][2][3]. Group 1: Clinical Trial Results - The DREAMS-2 trial involved 731 Chinese participants with type 2 diabetes, demonstrating that mazdutide 4 mg and 6 mg achieved mean reductions in HbA1c of 1.69% and 1.73%, respectively, compared to 1.36% for dulaglutide [2][3]. - At week 28, 71.2% and 74.2% of participants on mazdutide achieved HbA1c <7.0%, while 62.1% achieved this with dulaglutide [3]. - Participants on mazdutide experienced significant weight reductions of 9.24% and 7.13% for the 4 mg and 6 mg doses, respectively, compared to 2.86% for dulaglutide [4]. Group 2: Cardiometabolic Benefits - Mazdutide treatment led to improvements in multiple cardiometabolic risk factors, including fasting glucose, blood pressure, lipids, and liver enzymes, with results generally superior to dulaglutide [5]. - The treatment also showed a favorable safety profile, with low rates of treatment-emergent adverse events (TEAEs) leading to discontinuation and no new safety signals reported [6]. Group 3: Regulatory Status and Market Potential - Mazdutide is currently under review for two New Drug Applications (NDAs) in China: one for chronic weight management and another for glycemic control in type 2 diabetes [10]. - The company has multiple ongoing Phase 3 studies for mazdutide, indicating a strong pipeline and potential for significant market impact in diabetes treatment [10][11]. Group 4: Industry Context - The prevalence of diabetes in China is projected to reach 174 million by 2045, highlighting the urgent need for effective treatments [8]. - GLP-1 receptor agonists, including mazdutide, are becoming increasingly important in the management of type 2 diabetes, offering comprehensive benefits beyond glucose control [7].