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Innovent's Mazdutide Shows Superiority in Glycemic Control with Weight Loss over Semaglutide in a Head-to-head Phase 3 Clinical Trial DREAMS-3
Prnewswireยท 2025-10-27 00:00
Core Insights - Innovent Biologics announced that the fourth Phase 3 clinical trial DREAMS-3 of mazdutide has met its primary endpoint, demonstrating superior efficacy compared to semaglutide in Chinese patients with type 2 diabetes and obesity [1][2][3] Summary by Sections Clinical Trial Results - In the DREAMS-3 trial, 48.0% of participants in the mazdutide group achieved HbA1c < 7.0% and a 10% body weight reduction from baseline at week 32, compared to 21.0% in the semaglutide group (p<0.0001) [1][3] - The mean change in HbA1c from baseline was 2.03% for mazdutide and 1.84% for semaglutide, while the mean percentage weight reduction was 10.29% for mazdutide and 6.00% for semaglutide, both statistically significant (p<0.05) [1] Study Design - The DREAMS-3 trial was a multi-center, randomized, open-label study involving 349 Chinese adults with early-stage type 2 diabetes and obesity, who had inadequate glycemic and weight control after lifestyle interventions [2] - Participants were randomized to receive either mazdutide 6 mg or semaglutide 1 mg for 32 weeks, with an extension period for those on mazdutide based on weight-loss targets [2] Safety Profile - The overall safety profile of mazdutide was consistent with previous studies, with gastrointestinal symptoms being the most common adverse events, mostly mild to moderate in severity [1] Implications for Treatment - The results indicate that mazdutide could play a critical role in treating patients with type 2 diabetes and comorbid obesity, addressing both glycemic control and weight loss [1][2] - Mazdutide is positioned as a new-generation GLP-1-based therapy suitable for Chinese patients, with multiple metabolic benefits and a favorable safety profile [1] Company Background - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, autoimmune, cardiovascular, and metabolic disorders [8] - The company has launched 16 products and has several assets in clinical trials, indicating a robust pipeline and commitment to innovation in the biopharmaceutical sector [8]