Innovent Biologics (HKG: 1801) announced on October 27, 2025, that its fourth Phase III clinical study (DREAMS-3) for Mazdutide (IBI362), a Glucagon (GCG)/Glucagon-like Peptide-1 (GLP-1) dual receptor agonist, has met its primary endpoint.
Clinical Trial Results
The trial results indicated that in Chinese participants with Type 2 Diabetes (T2D) and comorbid obesity, the Mazdutide group achieved significantly better outcomes compared to the Semaglutide group. At Week 32, 48.0% of Mazdutide-treated participants achieved an HbA1c < 7.0% and a body weight reduction of ≥10% from baseline, compared to 21.0% in the Semaglutide group (P-value < 0.0001). The mean change in HbA1c from baseline was -2.03% in the Mazdutide group versus -1.84% in the Semaglutide group, while the mean percentage body weight reduction was 10.29% and 6.00%, respectively (both P-values < 0.05).
Safety Profile
Mazdutide demonstrated a safety profile consistent with previous trials, with no new safety signals identified. Gastrointestinal adverse reactions were the most common, mostly mild to moderate in severity.
Mechanism and Development
Mazdutide, co-developed by Innovent Biologics and Eli Lilly, is a mammalian oxyntomodulin (OXM) analog. It lowers blood glucose and reduces body weight by activating GLP-1R and increases energy expenditure by activating GCGR. Approved for marketing in China in June 2025, Mazdutide offers a novel approach to managing T2D and obesity.-Fineline Info & Tech
