Core Viewpoint - The article highlights the successful results of the phase III clinical trial (GLORY-2) for the drug IBI362 (Masitide) developed by Innovent Biologics, indicating its effectiveness in weight management for adults with moderate to severe obesity in China [4][6]. Group 1: Clinical Trial Results - The GLORY-2 study included 462 adult participants with a baseline average weight of approximately 94.0 kg and an average BMI of about 34.3 kg/m², with 16% having type 2 diabetes [4]. - At week 60, the Masitide 9 mg group experienced an average weight loss of 18.55%, compared to 3.02% in the placebo group, with 44.0% of participants in the Masitide group achieving a weight reduction of 20% or more [6]. - In the subgroup without type 2 diabetes, the Masitide group had an average weight loss of 20.08%, while the placebo group had 2.81%, with 48.7% of participants in the Masitide group achieving a weight reduction of 20% or more [6]. Group 2: Secondary Outcomes - The Masitide 9 mg group showed significant improvements in waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and uric acid levels compared to the placebo group [6]. - MRI-PDFF assessments indicated a 71.9% reduction in liver fat content in the Masitide group among participants with baseline liver fat content ≥10%, while the placebo group saw a 5.1% increase [6]. Group 3: Safety and Tolerability - Masitide 9 mg was well-tolerated, with no new safety signals identified; gastrointestinal adverse events were mostly mild to moderate and transient [6]. - The rate of treatment discontinuation due to adverse events was 2.9% in the Masitide group compared to 0% in the placebo group [6]. Group 4: Drug Mechanism and Development - Masitide is a dual receptor agonist for glucagon and GLP-1, promoting insulin secretion, reducing blood sugar, suppressing appetite, and enhancing energy expenditure and fat metabolism [7]. - Innovent Biologics has initiated or completed multiple phase III studies for Masitide, targeting various populations, including overweight or obese adults and patients with type 2 diabetes [7]. Group 5: Future Indications - The expansion of Masitide's indications is underway, including applications for adolescent obesity, metabolic-associated fatty liver disease (MASH), heart failure with preserved ejection fraction (HFpEF), and head-to-head trials with higher doses and other drugs [8].
速递｜平均减重18.55%！信达生物玛仕度肽公布针对中重度肥胖人群3期临床数据