Ascletis Pharma has announced that the US FDA has cleared its Investigational New Drug (IND) application for the Phase II study of ASC30, its oral small molecule GLP-1 therapy for type 2 diabetes.
The upcoming 13-week, randomized, double-blind, placebo-controlled, multi-center study will assess the efficacy, safety, and tolerability of ASC30 in roughly 100 participants with type 2 diabetes across multiple US sites.
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety. Participants will receive 40 mg, 60 mg, or 80 mg of ASC30—or matching placebo—with doses titrated weekly. Enrollment is slated to begin in the first quarter of 2026.
“IND clearance for this Phase II study for diabetes is a significant milestone for Ascletis as we continue to build upon the data for ASC30,” said Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis. “Furthermore, the FDA's clearance of our IND expands entry for ASC30 into clinical development for the large diabetes treatment market.”
The announcement follows the company’s recent completion of a 13-week Phase II study in obesity. In that trial, ASC30 demonstrated statistically significant, clinically meaningful, and dose-dependent body weight reductions of 5.4%, 7.0%, and 7.7% for 20 mg, 40 mg, and 60 mg doses, respectively.
No plateau in weight loss was observed, and gastrointestinal tolerability was favorable, with vomiting rates roughly half that reported for the comparator drug orforglipron. Overall discontinuation due to adverse events was just 4.8%.
ASC30, discovered and developed in-house at Ascletis, is the company’s first fully biased small molecule GLP-1 receptor agonist, designed for daily oral dosing as well as monthly-to-quarterly subcutaneous administration.
