GLP-1 receptor agonists

Search documents
Innovent announces the Phase 3 Clinical Study DREAMS-1 of Mazdutide in China were Orally Presented at ADA 85th Scientific Sessions
Prnewswireยท 2025-06-24 14:02
Core Insights - Innovent Biologics announced positive Phase 3 clinical study results for mazdutide, a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in treating type 2 diabetes (T2D) in Chinese adults, demonstrating significant efficacy in glycemic control and weight loss [1][8] Clinical Study Details - The DREAMS-1 study enrolled 319 Chinese participants with T2D inadequately controlled by diet and exercise, with a mean age of 50.4 years and a mean baseline HbA1c of 8.24% [2] - Participants were randomized to receive either mazdutide 4 mg, mazdutide 6 mg, or placebo for 24 weeks, with the primary endpoint being the change in HbA1c from baseline to week 24 [2] Efficacy Results - Mazdutide achieved an HbA1c reduction of 2.15% after 24 weeks, with 68.6% and 87.4% of participants on mazdutide 4 mg and 6 mg, respectively, achieving HbA1c <7.0%, compared to 10.7% with placebo [3] - Weight reduction was also significant, with participants on mazdutide 4 mg and 6 mg showing a percentage change in body weight of -5.61% and -7.81%, respectively, compared to -1.26% with placebo [4] Cardiometabolic Improvements - Treatment with mazdutide led to significant improvements in multiple cardiometabolic risk factors, including fasting glucose, waist circumference, blood pressure, and lipid levels [5] Safety Profile - Mazdutide exhibited a favorable safety profile, with low incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation, primarily mild to moderate gastrointestinal symptoms [6][7] Market Context - China has a high incidence of T2D, with approximately 140 million adult patients, highlighting the urgent need for effective treatment options [8][9] - The treatment landscape for diabetes is shifting towards a patient-centered approach, integrating glycemic control, weight management, and cardiovascular risk factor management [8] Future Prospects - Mazdutide has two New Drug Applications (NDAs) under review by China's National Medical Products Administration (NMPA) for chronic weight management and glycemic control in adults with T2D [11][12] - Innovent is actively developing a next-generation pipeline in the cardiovascular and metabolic fields, aiming to meet public health needs [12]