速递|体重减轻7.7%,歌礼制药口服GLP-1美国二期临床试验数据发布

Core Viewpoint - The article discusses the latest clinical results of GLP-1 oral weight loss drug ASC30 by Gilead Sciences, highlighting its competitive position in the oral weight loss drug market and comparing it with other leading products [5][6][7]. Summary by Sections Clinical Results of ASC30 - Gilead Sciences announced that ASC30 achieved a weight loss of 7.7% at the highest dose in a Phase II study involving 125 participants with obesity or overweight and at least one weight-related comorbidity [5]. - The study evaluated three dosing regimens (20mg, 40mg, and 60mg) with average weight loss of 5.4%, 7%, and 7.7% respectively, all statistically significant [5]. - No plateau in weight loss was observed during the trial period [5]. Comparison with Competitors - Gilead's data positions ASC30 in the upper-middle range of performance among oral weight loss drugs, with intense competition in the market [5]. - Novo Nordisk is awaiting FDA approval for its oral version of Wegovy, which demonstrated a weight loss of 15.1% over 68 weeks at a 50mg daily dose [5]. - Eli Lilly's orforglipron achieved a 12.4% weight loss over 72 weeks, but analysts noted persistent gastrointestinal side effects [6]. Safety and Tolerability - Gilead reported that the incidence of vomiting with ASC30 was about half that of orforglipron, with all gastrointestinal adverse events classified as grade 1-2 and occurring mainly during the dose escalation phase [7]. - No grade 3 or more severe events were reported, nor any serious drug-related adverse events [7]. - The CEO of Gilead indicated that ASC30 shows potential best-in-class characteristics in terms of weight loss efficacy and gastrointestinal tolerability [7]. Strategic Focus - Gilead plans to submit data to the FDA and apply for a Phase II end-of-study meeting in Q1 2026, having shifted its strategic focus to metabolic diseases earlier this year [7]. - Other competitors in the oral weight loss drug space include Viking Therapeutics, which reported a maximum weight loss of 12.2% in a Phase II study, but faced a 38% dropout rate among participants at the most effective dose [7].