Ascletis Doses First Patients in U.S. Phase IIa Trial of ASC30 for Obesity

Ascletis Doses First Patients in U.S. Phase IIa Trial of ASC30 for Obesity

By, Admin 28 July 2025

Ascletis Pharma Inc. (HKEX: 1672) announced that the first participants have been dosed in its U.S. Phase IIa clinical trial evaluating ASC30, a once-monthly subcutaneous (SQ) depot formulation of a small molecule GLP-1 receptor agonist, for the treatment of obesity and overweight with weight-related comorbidities.

About the Phase IIa Study

  • Trial Design: Randomized, double-blind, placebo-controlled, multi-center
  • Duration: 12 weeks
  • Participants were individuals with BMI ≥ 30 kg/m² (obesity) or BMI between 27–30 kg/m² (overweight) with at least one weight-related comorbidity
  • Cohorts: Three dose groups
  • Sample Size: Approximately 65 participants
  • Topline Data: Expected Q1 2026

Key Findings from Phase Ib SAD Study

In a completed U.S. Phase Ib single ascending dose (SAD) study, ASC30 demonstrated:

  • 36-day half-life in obese participants supporting once-monthly dosing
  • A peak-to-trough ratio of less than 2:1 at Day 29, indicating stable plasma concentration
  • Tolerability and pharmacokinetics aligned with best-in-class expectations for long-acting GLP-1 therapies

ULAP Technology: A Platform Without Albumin Constraints

ASC30 is powered by Ascletis’ proprietary Ultra-Long-Acting Platform (ULAP), which:

  • Has produced two small molecule compounds with exceptional half-lives such as ASC30 for 36 days and ASC47 for 40 days
  • Avoids limitations of albumin-dependent technologies, which are capped by albumin's ~20-day half-life
  • Enables superior tolerability by keeping the peak-to-trough ratio ≤ 2:1, a key benchmark for injectable incretins like semaglutide and tirzepatide

"Among all marketed or clinical-stage incretin drugs, ASC30 is the only once-a-month option with a half-life exceeding its dosing interval," said Dr. Jinzi Jason Wu, Founder, Chairman and CEO of Ascletis.

About ASC30

  • Class: First-in-class GLP-1 receptor biased small molecule agonist
  • Formulations: Once-daily oral tablet and once-monthly SQ injection
  • Unique Advantage: Single small molecule usable across both oral and injectable routes
  • Patent Protection: U.S. and global compound patents valid until 2044 (excluding extensions)
  • Indication: Obesity and metabolic disorders

About Ascletis Pharma Inc.

  • Founded: Listed on Hong Kong Stock Exchange (1672.HK)
  • Focus: Development and commercialization of first-/best-in-class metabolic disease therapies
  • Core Technologies: Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and ultra-Long-Acting Platform (ULAP)
  • Lead Program: ASC30, targeting obesity via oral and injectable routes

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