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
