Ascletis advances obesity treatment, preclinical data shows superior efficacy to tirzepatide

Ascletis Pharma Inc. has announced the selection of ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, as a clinical development candidate for obesity treatment. An Investigational New Drug Application (IND) submission to the U.S. FDA is anticipated in the second quarter of 2026. Preclinical data indicated ASC35 demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide in a head-to-head diet-induced obese (DIO) mouse study.

In head-to-head non-human primate (NHP) studies, ASC35 exhibited an average observed half-life of approximately 14 days, which is 6-fold longer than tirzepatide, supporting once-monthly human dosing. Furthermore, drug exposures of ASC35 administered intravenously and subcutaneously were approximately 80% and 70% greater, respectively, than tirzepatide in NHP studies. ASC35 also proved approximately 4-fold more potent than tirzepatide for both GLP-1R and GIPR in vitro.

ASC35 is being developed as both a monotherapy and in combination with other Ascletis compounds, including ASC36 and ASC47, for a range of cardiometabolic diseases such as obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH).