Core Insights - The article discusses the significant results of the DREAMS-1 clinical trial for the dual receptor agonist, IBI362 (Mastudutide), developed by Innovent Biologics, focusing on its efficacy in treating type 2 diabetes patients in China [1][2]. Group 1: Clinical Trial Results - The DREAMS-1 study achieved its primary and all key secondary endpoints by July 2024, demonstrating that Mastudutide effectively lowers blood sugar and promotes weight loss while positively impacting cardiovascular and renal metabolic indicators [1]. - The study included 320 Chinese type 2 diabetes patients with an average age of 50.4 years and a baseline HbA1c of 8.24%. Participants were randomly assigned to receive either 4 mg or 6 mg of Mastudutide or a placebo for 24 weeks [2]. Group 2: Efficacy in Glycemic Control - At 24 weeks, the HbA1c levels decreased by 1.57% and 2.15% for the 4 mg and 6 mg groups, respectively, compared to a mere 0.14% in the placebo group. The proportion of patients achieving HbA1c <7.0% was 68.6% and 87.4% for the treatment groups, while only 10.7% in the placebo group [3]. Group 3: Weight Loss Outcomes - Mastudutide also showed significant weight loss benefits, with the 4 mg and 6 mg groups experiencing weight reductions of 5.61% and 7.81%, respectively, compared to 1.26% in the placebo group. Additionally, 50.9% and 69.0% of patients in the treatment groups lost ≥5% of their body weight, while only 7.3% in the placebo group achieved this [5]. Group 4: Safety Profile - The overall tolerability of Mastudutide was good, with gastrointestinal adverse effects being the most common, primarily occurring during the titration phase. The incidence of hypoglycemia was low, with no severe cases reported, and the safety profile was consistent with previous studies [5].
速递｜多项代谢指标改善，信达生物口头报告玛仕度肽糖尿病3期临床研究结果