Ascletis’ ASC30 Shows Strong PK Data and Weight Loss Benefits in Phase Ib Study

Ascletis’ ASC30 Shows Strong PK Data and Weight Loss Benefits in Phase Ib Study

By, Admin 28 August 2025

Ascletis Pharma (HKEX:1672) has reported promising Phase Ib results for its investigational obesity therapy ASC30, an oral once-daily GLP-1 receptor agonist tablet. The U.S.-based study demonstrated both strong drug exposure and favorable tolerability compared with orforglipron.

Key Findings from Phase Ib Study (NCT06680440)

  • Design: Randomized, double-blind, placebo-controlled multiple ascending dose study in participants with obesity (BMI 30–40).
  • Drug exposure (AUC0–24h):
    - 20 mg cohort: 3,560 ng•h/mL
    - 40 mg cohort: 5,060 ng•h/mL
  • Weight loss (placebo-adjusted, 28 days):
    - 20 mg cohort: 4.5% reduction
    - 40 mg cohort: 6.5% reduction
  • Safety:
    - No serious adverse events (SAEs)
    - No Grade 3+ AEs, including GI events
    - No liver enzyme elevations (ALT, AST, TBL)
    - Normal vital signs, ECGs, and physical exams

Head-to-Head Advantage Over Orforglipron

  • In a cross-trial comparison, ASC30 exposure was significantly higher:
    - 20 mg ASC30: ~2.3x orforglipron (24 mg)
    - 40 mg ASC30: ~3.3x orforglipron (24 mg)
  • Weight reduction:
    - ASC30 20 mg: 4.5% vs orforglipron 24 mg: 3.6%
  • Tolerability:
    - ASC30 20 mg: no vomiting
    - Orforglipron 24 mg: 18% vomiting incidence [1]

These results suggest that higher drug exposure correlates with greater weight loss, while ASC30’s optimized chemistry improves tolerability.

Leadership Commentary

Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis, stated:

“I am pleased to see that ASC30 achieved drug exposures 2.3-fold to 3.3-fold higher than orforglipron in humans, consistent with preclinical findings. With greater weight loss and better tolerability, ASC30 may become a differentiated and competitive therapy for obesity.”

Next Steps

  • Phase IIa trial (U.S., 125 participants): Enrollment completed in August 2025.
  • Topline data expected: Q4 2025.

About ASC30

  • Mechanism: Biased GLP-1 receptor small molecule agonist.
  • Formulation flexibility: Same molecule designed for both oral tablet and subcutaneous injection.
  • Patent protection: Until 2044 (U.S. and global).

About Ascletis Pharma

A fully integrated biotech, Ascletis focuses on best-in-class and first-in-class therapies for metabolic diseases. The company leverages its AI-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) to advance a pipeline of innovative drug candidates, with ASC30 as its lead program.

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