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速递 | 24周减重10.3%!德睿智药首款「AI设计」小分子GLP-1 IIb期临床取得成功
GLP1减重宝典·2025-06-19 14:59

Core Viewpoint - The oral small molecule GLP-1RA drug MDR-001 developed by Derui Zhiya has successfully met clinical endpoints in a multi-center 24-week Phase IIb clinical trial for overweight or obese subjects, demonstrating significant weight loss and excellent safety and tolerability [2][3]. Group 1: Clinical Trial Overview - The Phase IIb clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 317 adult participants with obesity or overweight and at least one weight-related comorbidity [3]. - Participants had a baseline average weight of 90.1 kg and a BMI of 32.3 kg/m², with 53.5% being female [3]. - Subjects were randomly assigned to receive either MDR-001 at doses of 90mg, 120mg, 150mg, or 180mg, or a placebo for 24 weeks, with the primary endpoint being the percentage change in weight from baseline [3]. Group 2: Safety and Tolerability - MDR-001 demonstrated good safety and tolerability, with no serious adverse events related to the drug during the trial [4]. - The main adverse events were gastrointestinal reactions, such as nausea, vomiting, and diarrhea, which were mostly mild to moderate and occurred primarily in the first 6 weeks of the titration period [4]. - Only 0.8% of participants discontinued treatment due to adverse events, significantly lower than the 15%-50% discontinuation rate seen in other GLP-1 clinical trials [4]. Group 3: Weight Loss Results - Participants receiving MDR-001 experienced weight loss ranging from -8.2% to -10.3%, equating to absolute weight reductions of 7.4 kg to 9.2 kg, compared to a 2.4 kg loss in the placebo group [5]. - Between 70.9% and 85.4% of participants achieved a weight loss of at least 5%, while 34.5% to 48.1% lost at least 10% of their body weight [5]. - MDR-001 also showed promising results in improving various metabolic and cardiovascular parameters, including waist circumference, blood lipids, and blood pressure, indicating potential comprehensive clinical benefits for patients [5].