Ascletis Launches U.S. Phase I Obesity Trials for Once-Monthly Injections

The trials follow recent FDA clearance for the investigational new drug applications. Each study is a randomized, double-blind, placebo-controlled trial assessing safety, pharmacokinetics, and pharmacodynamics in participants with obesity or overweight conditions with related comorbidities. The ASC36_35FDC trial involves 176 participants across two formulations, while the ASC36 monotherapy study includes 144 subjects.

These candidates utilize the company's proprietary Self-Assembling Lipid Depot technology, which allows for a low-viscosity solution to form a slow-release gel-like depot upon subcutaneous administration. CEO Jinzi Jason Wu noted that by targeting the amylin receptor, GLP-1R, and GIPR pathways, the triple-combination injection aims to reduce the burden of frequent dosing while potentially improving weight-loss outcomes. Preclinical data in animal models suggest that the ASC36_35FDC formulation could provide significant relative body weight reduction compared to current standard-of-care co-administrations.