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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
The Phase II study will enroll about 100 U.S. participants with type 2 diabetes to assess ASC30’s efficacy and safety over 13 weeks, following promising obesity trial results.
- Yesterday, Ascletis Pharma Inc. said the U.S. Food and Drug Administration cleared an IND for a Phase II study of ASC30 in participants with type 2 diabetes mellitus, with enrollment expected in the first quarter of 2026.
- Prior Phase II obesity results demonstrated ASC30 placebo-adjusted weight reductions of 5.4%, 7.0% and 7.7% with no hepatic safety signal and total discontinuation rate 4.8%.
- The Phase II study is a randomized, double-blind, placebo-controlled, multi-center trial enrolling approximately 100 participants, with randomization ratio 2:3:3:2 to ASC30 doses and placebo, titrated weekly from 1 mg.
- Following IND clearance, Ascletis highlighted clinical entry into the diabetes market, with Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, calling it a significant milestone expanding ASC30 development.
- As an oral small-molecule GLP-1R fully biased agonist, ASC30 developed in-house showed comparable gastrointestinal tolerability and a vomiting rate approximately half that of orforglipron.
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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
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.
Ascletis receives FDA approval for diabetes mellitus clinical trial of ASC30
Ascletis Pharma has received IND clearance from the FDA to begin a 13-week Phase II study of its oral small molecule GLP-1, ASC30, targeting participants with type 2 diabetes mellitus.The post Ascletis receives FDA approval for diabetes mellitus clinical trial of ASC30 appeared first on Clinical Trials Arena.
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