Ascletis Announces U.S. FDA IND Clearance for Phase I Study of Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for the Treatment of Obesity

Ascletis Announces U.S. FDA IND Clearance for Phase I Study of Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for the Treatment of Obesity

PR Newswire

HONG KONG, June 23, 2026

Phase I trial consists of two parts. Part A is a single ascending dose (SAD) study of ASC35 once-monthly Self-Assembling Lipid Depot (SALD) formulation; Part B is a head-to-head study of multiple ascending doses (MAD) of ASC35 once-monthly SALD formulation compared to the U.S. Food and Drug Administration (FDA)-authorized tirzepatide once-weekly formulation.In head-to-head non-human primate (NHP) studies, the average observed half-life of ASC35 was approximately six-fold longer than tirzepatide, which supports once-monthly subcutaneous (SQ) dosing in humans. In a head-to-head diet-induced obese (DIO) mouse study, ASC35 demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide.HONG KONG, June 23, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase I study of ASC35, a potentially best-in-class, once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, for the treatment of obesity.