- The proportion of participants achieving HbA1c < 7.0% and a ≥10% reduction in body weight from baseline was 48.0% in the mazdutide group and 21.0% in the semaglutide group
- DREAMS-3 is the world’s first Phase 3 clinical trial of a GCG/GLP-1 dual receptor agonist to conduct a head-to-head comparison with semaglutide in diabetes treatment
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the fourth Phase 3 clinical trial DREAMS-3 of mazdutide, a glucagon-like peptide-1 (GLP-1) and glucagon (GCG) dual receptor agonist, has met its primary endpoint. The results demonstrated that, in Chinese patients with type 2 diabetes (T2D) and obesity, mazdutide showed superior efficacy to semaglutide on the primary endpoint—the proportion of participants achieving HbA1c < 7.0% and ≥10% body weight reduction from baseline at week 32 (48.0 vs. 21.0%, p<0.0001). In addition, at week 32, the mean change in HbA1c from baseline was −2.03% in the mazdutide group and −1.84% in semaglutide group, respectively, and the mean percentage weight reduction from baseline was 10.29% in the mazdutide group and 6.00% in the semaglutide group, respectively (both p<0.05). During the study, the overall safety profile of mazdutide was consistent with previous clinical studies, with no new safety signals identified. Gastrointestinal symptoms were the most common adverse events, mostly mild to moderate in severity.
Professor Linong Ji, the Principal Investigator of the DREAMS-3, Peking University People’s Hospital, stated: “Diabetes and obesity share similar epidemic trends. Among the vast population with T2D in China, the proportion of those with comorbid obesity has been increasing. Previous studies have indicated that, compared with non-obese patients with diabetes, patients with T2D and comorbid obesity experience more challenging glycemic control, along with a significant increase in cardiovascular mortality risk and overall cardiovascular disease risk. Therefore, treatment strategies that address both glycemic control and weight loss are playing an increasingly critical role in improving clinical outcomes for patients with T2D and comorbid obesity. In recent years, GLP-1 receptor agonists have become a key therapeutic option for type 2 diabetes—particularly for patients with comorbid obesity—owing to their benefits, including glycemic control, weight reduction, and cardiorenal protection. As the world’s first approved GCG/GLP-1 dual receptor agonist, mazdutide has demonstrated superior efficacy in glucose lowering and weight loss over semaglutide in the latest Phase 3 clinical trial; mazdutide also provides multiple metabolic benefits and has a favorable safety profile, making it a new-generation GLP-1-based therapy suitable for Chinese patients. We believe that mazdutide can bring benefits to patients with T2D and comorbid obesity who are appropriate candidates for this class of therapy—to control blood glucose, effectively manage weight, and improve overall health status.”
Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent Biologics, stated: “China has a large number of patients with obesity and other comorbidities, underscoring an urgent need for more effective, safer, and more convenient innovative therapies. Mazdutide is the world’s first and only approved GCG/GLP-1 dual receptor agonist indicated for both weight management and the treatment of T2D. Previous registrational studies in Chinese T2D participants (DREAMS-1 and DREAMS-2) have demonstrated mazdutide’s benefits across glycemic control, weight reduction, and multiple metabolic indicators. The head-to-head DREAMS-3 study comparing mazdutide with semaglutide further showed that, in patients with T2D and comorbid obesity, mazdutide provides superior efficacy in both weight loss and glucose lowering. With successive approvals for weight management and T2D indications, we believe mazdutide will benefit a wide range of patients requiring multifaceted improvements in glycemic control, body weight, and cardiometabolic risk factors.”
