Ascletis Initiates Phase IIa Study of Innovative Obesity Drug ASC30 in the U.S.

Ascletis Initiates Phase IIa Study of ASC30

Ascletis Pharma Inc., a fully integrated biotechnology company, proudly announces the initiation of its U.S.-based Phase IIa clinical trial for ASC30, an innovative GLP-1 receptor agonist aimed at treating obesity. This follows the successful dosing of the first participants in this 12-week, randomized, double-blind, placebo-controlled study. The focus is primarily on individuals who are either overweight or obese and exhibit at least one weight-related comorbidity.

The ASC30 candidate stands out due to its once-monthly subcutaneous depot formulation, which is specifically designed for sustained release. In prior Phase Ib studies, the ultra-long-acting ASC30 demonstrated an impressive half-life of 36 days, thereby supporting a once-monthly administration approach. Notably, this formulation achieved a peak-to-trough concentration ratio of less than 21—a metric that is pivotal for ensuring tolerability in clinical applications of incretin therapies.

Professor Jinzi Jason Wu, the founder and CEO of Ascletis, highlighted the significance of this trial: “ASC30 once-monthly SQ depot formulation is unique in its extended half-life, surpassing the typical limitations faced by many incretin drugs currently available.” This underscores the potential of ASC30 as a pioneering solution in the fight against obesity, a condition that has reached epidemic proportions globally.

The Phase IIa study will encompass three different dosing cohorts, with approximately 65 participants involved. By the first quarter of 2026, topline data from the study is anticipated to emerge, providing valuable insights into the safety and efficacy of ASC30.

About ASC30

ASC30 is a novel GLP-1 receptor biased small molecule agonist developed entirely in-house at Ascletis. Notable for its unique properties, it enables dual administration, both orally and subcutaneously. It represents a significant advancement in obesity management, covering an unmet need in therapeutics that could change the landscape of treatment. The compound also benefits from a robust patent portfolio, protecting it until 2044.

Ascletis Pharma Inc.

Ascletis Pharma is firmly committed to developing and commercializing innovative therapeutics targeting metabolic disorders. Utilizing advanced technologies like its AI-Assisted Structure-Based Drug Discovery Platform, the company is positioned at the forefront of biopharmaceutical innovation. Through its strategic initiatives, Ascletis aims to provide groundbreaking solutions for individuals battling obesity and improve their overall health outcomes.

For more information about Ascletis Pharma and ASC30, please visit Ascletis.