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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
GLP1减重宝典· 2025-12-11 03:34
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].
诺和诺德(NVO.US)口服版Wegovy减肥药获美国FDA受理申请
智通财经网· 2025-05-03 03:30
Group 1 - Novo Nordisk's oral weight loss drug Wegovy has had its application formally accepted by the FDA, with a decision expected in Q4 [1] - If approved, Wegovy will be the first oral GLP-1 receptor agonist for chronic weight management globally [1] - Novo Nordisk's stock price rose by 5.53% to $69.23 following the announcement [1] Group 2 - The company currently markets Rybelsus, an oral GLP-1 drug approved for blood sugar control in adults with diabetes [1] - The global obesity treatment market is projected to exceed $150 billion in the coming years [1] - Eli Lilly's experimental oral drug orforglipron showed an average weight loss of 16 pounds (approximately 7.3 kg) in type 2 diabetes patients after 40 weeks [1] Group 3 - Novo Nordisk's application is based on a pivotal Phase III clinical trial involving 307 obese adults with at least one comorbidity, comparing 25 mg oral semaglutide to a placebo [2] - The company is also developing a new generation weight loss drug, amycretin, which targets both GLP-1 and the pancreatic hormone amylin to regulate hunger [2] - Concerns have arisen among investors regarding competition from Eli Lilly and disappointing clinical trial data for Novo Nordisk's candidate CagriSema, which was expected to be a strong alternative to Wegovy [2]