Ascletis Pharma has announced that it has received the Investigational New Drug (IND) clearance from the US 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, randomised, double-blind, placebo-controlled and multi-centre 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 the placebo group and safety and tolerability.
The Phase II study will enrol around 100 patients with type 2 diabetes across multiple US sites.
Participants will be randomised in a 2:3:3:2 ratio to receive ASC30 at target doses of 40 mg, 60 mg or 80 mg, or placebo, following weekly titration from 1 mg.
Enrolment is expected to begin in Q1 2026.
Ascletis has already completed a 13-week Phase II study of ASC30, an oral small-molecule GLP-1 receptor agonist, in 125 participants with obesity or overweight and at least one weight-related comorbidity across multiple US sites.
At the primary endpoint, once-daily ASC30 achieved statistically significant, dose-dependent placebo-adjusted mean weight reductions of 5.4%, 7.0% and 7.7% at 20 mg, 40 mg and 60 mg, respectively, with no plateau observed.
Weekly titration resulted in a vomiting rate around half that reported for orforglipron, with overall gastrointestinal tolerability comparable to Phase III ATTAIN-1 data and a treatment discontinuation rate due to adverse events of 4.8%.
ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist designed to be dosed once daily orally and once monthly to once quarterly subcutaneously for the treatment of obesity, diabetes and other metabolic diseases.
"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 Dr Jinzi Jason Wu, founder, Chair 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."