Ascletis Pharma Wins FDA IND Clearance for Phase II Diabetes Study

Reuters
Jan 05
Ascletis Pharma Wins FDA IND Clearance for Phase II Diabetes Study

Ascletis Pharma Inc. has announced that it has received Investigational New Drug $(IND)$ clearance from the U.S. Food and Drug Administration (FDA) for a 13-week Phase II clinical study of its oral small molecule GLP-1 candidate, ASC30, in participants with type 2 diabetes mellitus. The upcoming study will be randomized, double-blind, placebo-controlled, and multi-center, aiming to evaluate the efficacy, safety, and tolerability of ASC30. Enrollment for the trial is expected to begin in the first quarter of 2026.

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