ASC35 / Ascletis - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Ascletis Pharma (China) Co., Limited

New P1 trial • Genetic Disorders • Obesity

Co-formulation of ASC36 and ASC35, once-monthly amylin receptor agonist and GLP-1R/GIPR agonist, demonstrated superior weight loss to eloralintide/tirzepatide combo in DIO rats (EASD 2026) - "Animals were randomly divided into 4 groups (N=7 in each group) including vehicle control group, eloralintide_tirzepatide FDC group, MET-233i_tirzepatide FDC group and ASC36_35 FDC group. Based on these encouraging preclinical data, we believe ASC36_35 FDC has the potential to lead to greater weight loss reduction in people with obesity. The clinical studies of ASC36_35 FDC are warranted."

Preclinical • Metabolic Disorders • 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 (PRNewswire) - "The Phase I trial is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 following single and multiple ascending doses in 84 participants with obesity (body mass index (BMI) ≥30.0 kg/m²) or overweight (BMI ≥27.0 kg/m²) with weight-related comorbidities."

IND • New P1 trial • Obesity

ASC35, a Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist Peptide, demonstrated 14-day average observed half-life, 6-fold longer than tirzepatide, in NHP model and 71% more relative weight loss than tirzepatide in DIO mouse model (ECO 2026) - "ASC35's longer observed half-life, better SQ bioavailability and greater weight loss compared to tirzepatide demonstrate its potential as a best-in-class treatment for obesity. Jinzi Jason Wu: Employee of Ascletis Pharma (China) Co., Lmited; Kunhuan Dong and Chengfei Wu: Employees of an affiliate of Ascletis Pharma (China) Co., Limited"

Preclinical • Genetic Disorders • Obesity

ASC36, a Once-Monthly Next-Generation Amylin Receptor Agonist Peptide, demonstrated 32-day average observed half-life, 6-fold longer than petrelintide, in NHP model and 91% more relative weight loss than petrelintide in DIO rat model (ECO 2026) - "ASC36 has excellent chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation with other peptides including ASC35, a GLP-1R/GIPR dual agonist. ASC36's longer observed half-life and greater weight loss demonstrate its potential as a best-in-class once-monthly amylin receptor agonist for the treatment of obesity. Nymble. ClR provides obesity clinical care in the My Best Weight clinic and Beyond BMI clinic and is a co-owner of these clinics."

Preclinical • Genetic Disorders • Obesity

Ascletis to Present Data on Multiple Programs at the 33rd European Congress on Obesity (ECO 2026) (PRNewswire) - "The presentations include a poster on the Phase I data of ASC47, an adipose-targeting thyroid hormone receptor beta (THRβ) agonist for muscle-preserving weight loss, which, in combination with semaglutide, demonstrated up to 111.8% greater relative weight loss in participants with obesity compared to semaglutide monotherapy, and a poster on the preclinical data of ASC36, a once-monthly next-generation amylin receptor agonist peptide, which demonstrated 32-day average observed half-life, 6-fold longer than petrelintide, in non-human primate (NHP) model and 91% more relative weight loss than petrelintide in diet-induced obese (DIO) rat model."

P1 data • Preclinical • Obesity

Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development (PRNewswire) - "ASC36 monotherapy demonstrated approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in a head-to-head diet-induced obese (DIO) rat study, while ASC35 monotherapy demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in a head-to-head DIO mouse study....Co-formulation of ASC36 and ASC35 demonstrated approximately 51% greater relative body weight reduction....Submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for co-formulation of ASC36 and ASC35 is expected in the second quarter of 2026."

IND • Preclinical • Obesity

Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development (PRNewswire) - "ASC35 demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide in a head-to-head diet-induced obese (DIO) mouse study. Submission of an Investigational New Drug Application (IND) for ASC35 to the U.S. Food and Drug Administration (FDA) is expected in the second quarter of 2026."

IND • Preclinical • Obesity