Business
Ascletis Announces First Participants Dosed in a 13-week U.S. Phase II Study with ASC30, an Oral Small Molecule GLP-1R Agonist for the Treatment of Diabetes
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase II study (NCT07321678) with ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus. Topline data from the Phase II study are expected in the third quarter of 2026.
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"-Topline data from the Phase II study for the treatment of diabetes are expected in the third quarter of 2026.","length":115,"tagName":"p"},{"type":"text","content":"-ASC30 demonstrated placebo-adjusted weight loss of up to 7.7% in a recently completed 13-week U.S. Phase II study in participants with obesity or overweight, with better gastrointestinal tolerability. No hepatic safety signal was observed.","length":245,"tagName":"p"},{"type":"text","content":"HONG KONG, Jan. 25, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase II study (NCT07321678) with ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus. Topline data from the Phase II study are expected in the third quarter of 2026.","length":402,"tagName":"p"},{"type":"text","content":"Ascletis recently completed a 13-week Phase II study evaluating ASC30 for the treatment of obesity (NCT07002905) in 125 participants with obesity or overweight with at least one weight-related comorbidity at multiple sites across the U.S. At the 13-week primary endpoint, ASC30 once-daily tablets showed statistically significant, clinically meaningful and dose-dependent placebo-adjusted mean body weight reductions of 5.4%, 7.0% and 7.7% for 20 mg, 40 mg and 60 mg, respectively. No plateau was observed for weight loss. The vomiting rate of ASC30 titrated weekly to target dose was approximately half of the published vomiting rate observed with orforglipron titrated weekly. The gastrointestinal tolerability of ASC30 titrated weekly was comparable to published results of orforglipron titrated every four weeks in the Phase III ATTAIN-1 study. The total treatment discontinuation rate due to adverse events for the ASC30 Phase II study for obesity or overweight was 4.8%.","length":991,"tagName":"p"},{"type":"text","content":"ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist that can be dosed once daily orally and once monthly to once quarterly subcutaneously for the treatment of obesity, diabetes and other metabolic diseases.","length":289,"tagName":"p"},{"type":"text","content":""Expanding ASC30's clinical development...