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Ascletis Announces U.S. FDA IND Clearance for 13-Week Phase II Study of Its Oral Small Molecule GLP-1, ASC30, in Participants with Diabetes
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase II study of its oral small molecule GLP-1, ASC30, in participants with diabetes. The Phase II study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with type 2 diabetes mellitus. The primary end
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[{"type":"text","content":"-The Phase II study for diabetes is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with diabetes. Enrollment is expected to begin in the first quarter of 2026.-ASC30 demonstrated placebo-adjusted weight loss of 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":508,"tagName":"p"},{"type":"text","content":"HONG KONG, Jan. 4, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase II study of its oral small molecule GLP-1, ASC30, in participants with diabetes. The Phase II study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with type 2 diabetes mellitus. The primary endpoint of the Phase II study is the mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group. Secondary endpoints include the mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group, the mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group, and safety and tolerability. The Phase II study will enroll approximately 100 participants with type 2 diabetes mellitus at multiple sites across the U.S. Participants will be randomly assigned in a ratio of approximately 2:3:3:2 to 40 mg, 60 mg and 80 mg ASC30 tablets and matching placebo tablets, respectively. ASC30 will be titrated weekly from 1 mg to target doses of 40 mg, 60 mg and 80 mg. Enrollment is expected to begin in the first quarter of 2026.","length":1435,"tagName":"p"},{"type":"text","content":"Ascletis recently completed its 13-week Phase II study evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist 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 prim...