Core Insights - The Phase II study of ASC30, an oral GLP-1 receptor agonist for obesity treatment, has shown positive topline results, demonstrating statistically significant and clinically meaningful weight loss compared to placebo [1][2] Group 1: Study Results - The study involved 125 participants with obesity or overweight with at least one weight-related comorbidity, assessing three doses of ASC30 (20 mg, 40 mg, and 60 mg) [1] - At week 13, the average weight loss relative to baseline was 5.4%, 7.0%, and 7.7% for the 20 mg, 40 mg, and 60 mg doses respectively, all showing statistical significance (p < 0.0001) [1] - 80.0% of participants receiving 60 mg ASC30 experienced a weight loss of ≥5%, compared to 4.2% in the placebo group [2] Group 2: Secondary and Exploratory Endpoints - ASC30 also achieved secondary and exploratory endpoints by reducing cardiovascular risk markers, including total cholesterol, LDL-C, triglycerides, systolic and diastolic blood pressure across all dose groups [2] Group 3: Safety and Tolerability - The overall discontinuation rate due to adverse events was 4.8%, with gastrointestinal adverse events being the primary cause [4] - No severe gastrointestinal adverse events were reported, and the tolerability of ASC30 was comparable to orforglipron, with a lower incidence of vomiting [3][4] - No liver safety signals were observed, and laboratory tests showed no significant abnormalities [4] Group 4: Future Plans - The company plans to submit data to the FDA and request an End-of-Phase II meeting in Q1 2026, anticipating further improvements in gastrointestinal tolerability in Phase III studies [4]
歌礼制药-B(01672)：ASC30治疗肥胖症的13周II期研究取得积极的顶线结果