效果良好 华东医药口服式减重药Ⅱ期临床结果出炉

Core Insights - East China Pharmaceutical's innovative drug HDM1002 has shown excellent results in Phase II clinical trials for weight loss, demonstrating good efficacy and safety [1][2][3] Group 1: Clinical Trial Results - HDM1002 was tested in a 16-week Phase II clinical trial involving 185 participants, focusing on its safety and efficacy in overweight or obese individuals without diabetes [1] - After 12 weeks of treatment, the percentage change in weight from baseline for the HDM1002 100mg BID, 200mg BID, 400mg QD groups, and placebo group were -4.63%, -6.08%, -6.83%, and -2.88% respectively, with the 200mg BID and 400mg QD groups showing statistically significant differences compared to the placebo [2] - Sensitivity analysis confirmed similar results, with weight reductions of -5.39%, -7.01%, -8.46%, and -2.87% for the respective groups, and 63.0% and 56.5% of participants in the 200mg BID and 400mg QD groups losing ≥5% of their baseline weight, significantly higher than the placebo group [2] Group 2: Safety Profile - Most treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were mild, with no severe adverse events reported; the most common TEAEs were gastrointestinal issues such as nausea, vomiting, and diarrhea [3] - No trends of elevated liver enzymes were observed across the HDM1002 dosage groups [3] Group 3: Future Developments - The successful Phase II trial results mark a significant milestone in the development of HDM1002, leading to the approval for Phase III clinical research by the Center for Drug Evaluation (CDE) [3] - East China Pharmaceutical has developed a comprehensive product pipeline targeting GLP-1, including oral tablets and injectables, with ongoing clinical trials for other innovative drugs such as HDM1005 and DR10624 [3]