Ascletis Pharma has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate a Phase I study of ASC35 for obesity.
ASC35 is a once-monthly subcutaneous (SQ) glucagon-like peptide-1 receptor/glucose-dependent insulinotropic polypeptide receptor (GLP-1R/GIPR) dual peptide agonist.
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The placebo-controlled, randomised, double-blind trial included 84 participants with obesity (body mass index (BMI) ≥30.0kg/m²) or those overweight (BMI ≥27.0kg/m²) with weight-related comorbidities.
It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ASC35 through single and multiple ascending doses.
The clinical trial will be conducted in two parts. Part A is a single-ascending dose (SAD) study of ASC35 using Ascletis’ once-monthly Self-Assembling Lipid Depot (SALD) formulation.
Part B features a head-to-head, multiple-ascending-dose (MAD) comparison between ASC35’s once-monthly SALD formulation and the FDA-approved, once-weekly tirzepatide.
ASC35 was independently discovered and developed using Ascletis’ AI-assisted structure-based drug discovery (AISBDD) platform, and its SALD formulation was made using the ultra-long-acting platform (ULAP) technology.
The SALD formulation, a low-viscosity solution containing lipids, organic solvents, and the active ingredient, is designed for subcutaneous injection and transforms into a gel-like depot that gradually releases the drug over one month or longer.
Ascletis founder, chairman and CEO Jinzi Jason Wu said: “The FDA’s IND clearance for ASC35 once-monthly utilising our proprietary SALD formulation is an exciting and significant milestone for Ascletis’ peptide pipeline to treat obesity as we advance multiple once-monthly to once-quarterly SQ administered peptides into the clinic.
“ASC35’s potential for superior weight loss combined with a more versatile and patient-friendly once-monthly SQ injection will address a major unmet need in the rapidly growing obesity market.”
In April 2026, Ascletis Pharma completed subject enrolment in its 13-week US Phase II study of ASC30, an oral small-molecule GLP-1 receptor agonist, as a treatment for type 2 diabetes mellitus.
