Ascletis Pharma has dosed the first obese or overweight subjects in the 13-week, multi-centre US Phase IIa trial of ASC30.
The dosing was performed in those identified with at least one weight-related comorbidity.
Go deeper with GlobalData
The double-blind, randomised and placebo-controlled trial aims to assess the safety, tolerability, and efficacy of the oral treatment in individuals with a body mass index (BMI) of 30kg/m² or higher, or those overweight with a BMI of at least 27kg/m² but less than 30kg/m².
Two oral formulations of the therapy, formulation one (ASC30 tablets) and formulation two (ASC30 tablets A1), both administered once a day, are under evaluation.
The mean percentage change in body weight from baseline at week 13 is the trial’s primary endpoint.
The trial’s design incorporates insights from previous Phase Ia and Ib studies, suggesting a lower starting dose and a slower titration strategy for the once-a-day administration of the oral therapy.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIts protocol includes a lower starting dose of 1mg of both formulations, and will gradually increase the dosage to maintenance levels of 20mg and 40mg for formulation one, or 20mg, 40mg, and 60mg for formulation two, on a weekly basis.
The Phase IIa trial’s topline data are anticipated in the fourth quarter of this year.
In earlier Phase Ia single ascending dose (SAD) studies, formulation two of ASC30 showed a flatter pharmacokinetic profile compared to formulation one.
Ascletis Pharma CEO, chairman and founder Jinzi Jason Wu said: “We are happy that we are ahead of the schedule of our US 13-week Phase IIa study since we have initiated screening of participants in June and recently completed dosing of the first participants.
“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.”
ASC30, the in-house discovery of Ascletis, is a small-molecule glucagon-like peptide-1 receptor (GLP-1R)-biased agonist.
This new chemical entity has patent protection in the US and globally until 2044, with no patent extensions.
In April 2025, Ascletis reported early weight loss results from a Phase Ib trial of ASC30.
