Ascletis Pharma Inc., a fully integrated biotech company, has completed patient enrollment in its U.S.-based Phase IIa clinical trial evaluating ASC30, a novel small-molecule GLP-1 receptor (GLP-1R) agonist developed for obesity treatment.
Rapid Enrollment Signals High Demand for New Obesity Treatments
- The trial enrolled 125 participants in just over one month.
- Participants are obese or overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbidity.
- The fast-paced enrollment reflects the urgent unmet need for new obesity therapies beyond injectables.
“This milestone brings us one step closer to delivering a differentiated treatment for obesity. We anticipate topline data by Q4 2025.”
- Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis.
Inside the ASC30 Phase IIa Study
The Phase IIa trial (NCT07002905) is a 13-week, randomized, double-blind, placebo-controlled, multicenter study assessing:
- Primary endpoint: Mean percentage change in body weight from baseline at Week 13.
- Two oral formulations under investigation:
- Formulation 1: Maintenance doses of 20 mg and 40 mg.
- Formulation 2: Maintenance doses of 20 mg, 40 mg, and 60 mg. - Dose titration begins at 1 mg weekly.
Both formulations were previously evaluated in a Phase Ia SAD study (NCT06680440). Formulation 2 exhibited a flatter pharmacokinetic profile, potentially offering more stable drug exposure.
ASC30: A Differentiated Oral GLP-1R Agonist with Dual Dosing Potential
What sets ASC30 apart:
- First-in-class small molecule GLP-1R biased agonist.
- Offers both once-daily oral dosing and once-monthly subcutaneous injection—unlike peptide-based GLP-1 drugs.
- Developed in-house at Ascletis as a new chemical entity (NCE).
- Patent protection extends globally to 2044, excluding extensions.
About Ascletis Pharma
Ascletis is focused on first-in-class and best-in-class therapeutics for metabolic diseases. The company has a strong pipeline targeting unmet needs in obesity, NASH, and other chronic metabolic conditions.
