Ascletis Pharma Completes Enrollment for Phase IIa Study of Oral GLP-1R Agonist ASC30 in Obesity Treatment

Ascletis Pharma Completes Enrollment for Phase IIa Study of Oral GLP-1R Agonist ASC30 in Obesity Treatment

By, Admin 6 August 2025

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.

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