歌礼制药-B(01672.HK):口服小分子GLP-1药物ASC30在肥胖或超重受试者中进行的美国13周II期研究显示经安慰剂校正后的体重下降高达7.7%,且胃肠道耐受性更佳

Core Viewpoint - The company has announced positive topline results from a 13-week Phase II study of the oral small molecule GLP-1 receptor agonist ASC30 for the treatment of obesity, indicating significant weight loss compared to placebo [1][2] Group 1: Study Results - The Phase II study involved 125 obese or overweight participants with at least one weight-related comorbidity, conducted across multiple centers in the United States [1] - All three doses of ASC30 (20 mg, 40 mg, and 60 mg) achieved the primary endpoint, showing statistical significance (p-values < 0.0001) and clinical relevance in weight reduction compared to placebo [1] - The average weight loss at week 13, adjusted for placebo, was as high as 7.7% for the 60 mg dose of ASC30 [1] Group 2: Future Plans - The CEO expressed optimism about the Phase II results, highlighting ASC30's potential for weight loss and gastrointestinal tolerance, suggesting it may be best-in-class [2] - The company anticipates further improvement in gastrointestinal tolerance during the Phase III study, where dosing will shift to every four weeks [2] - Plans are in place to submit data and request an End-of-Phase II meeting with the FDA in the first quarter of 2026 [2]