Ascletis completes enrolment in US study assessing ASC30 oral GLP-1R agonist

Ascletis Pharma has completed enrolment in its US 13-week Phase IIa study evaluating ASC30, a small molecule oral GLP-1 receptor (GLP-1R) agonist for the treatment of obesity.

ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly subcutaneously for the treatment of obesity.

"We are excited to announce this important milestone, which brings us another step closer to delivering ASC30 as a potential unique and differentiated treatment for obesity," said Dr Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, "The rapid pace of enrolment of 125 participants in just over one month underscores the unmet medical need for additional treatment options for obesity. We are looking forward to topline data from this Phase IIa study in the fourth quarter 2025. As a small molecule, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for obesity treatment, if approved."

The Phase IIa study is a 13-week, randomised, double-blind, placebo-controlled and multi-centre study to evaluate the efficacy, safety, and tolerability in participants with obesity (body mass index (BMI) ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2 but < 30 kg/m2) with at least one weight-related comorbidity. Two oral formulations of one-daily ASC30 are being evaluated: formulation 1 (ASC30 tablets) and formulation 2 (ASC30 tablets A1).

The primary endpoint of the study is the mean percentage body weight change from baseline at Week 13. The 13-week study protocol has a low starting dose of 1 mg of both formulation 1 and formulation 2, with weekly titrations to the desired maintenance doses of 20 mg and 40 mg of formulation 1 or 20 mg, 40 mg and 60 mg of formulation 2.