速递|全年减重超30斤,信达生物玛仕度肽再披露关键临床数据

Core Insights - The article discusses the Phase II clinical trial results of the GLP-1/GCG dual receptor agonist, Ma Shidu (玛仕度肽), developed by Innovent Biologics, which showed significant weight loss and metabolic improvements in obese participants [4][5]. Group 1: Clinical Trial Results - The Phase II trial included 80 Chinese adult participants with obesity (BMI ≥ 30 kg/m²), with an average baseline weight of 96.9 kg [4]. - At week 24, the Ma Shidu 9 mg group achieved a weight loss of 15.4% compared to the placebo, with 81.7% of participants losing over 5%, 65.0% over 10%, and 21.7% over 20% [5]. - By week 48, weight loss increased to 18.6%, with 34.9% of participants losing over 20% of their body weight, equating to more than 30 pounds based on baseline weight [5]. Group 2: Metabolic Improvements - The study also reported improvements in various cardiovascular and metabolic indicators, including waist circumference, blood pressure, blood lipids, and uric acid levels [5]. - For participants with baseline liver fat content ≥ 5%, liver fat content decreased by 73.3% at week 24, with 83.3% of participants returning to normal liver fat levels [5]. Group 3: Safety Profile - The safety profile of Ma Shidu was favorable, with no serious adverse events reported and no participants discontinuing due to adverse reactions [5]. - The most common adverse effects were mild to moderate gastrointestinal symptoms, primarily occurring during the dose escalation phase [5]. Group 4: Regulatory and Development Status - Ma Shidu is a collaboration between Innovent Biologics and Eli Lilly, and it is expected to be approved in China for long-term weight management in overweight or obese adults by June 2025 [5]. - The Phase III clinical trial (GLORY-2) for the 9 mg dose has reached its primary endpoint, showing a weight reduction of 20.1%, and the related market application has been accepted [5].

速递|全年减重超30斤,信达生物玛仕度肽再披露关键临床数据 - Reportify