ASC36i / Ascletis - LARVOL DELTA

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 Initiation of Two Phase I Studies in U.S. for the Treatment of Obesity: ASC36 Once-Monthly Injection, an Amylin Receptor Peptide Agonist, and ASC36_35FDC Once-Monthly Injection, a Co-Formulation of ASC36 and GLP-1R/GIPR Peptide Agonist ASC35 (The Manila Times) - "The Phase I study for ASC36_35FDC is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36_35FDC injections following single and multiple ascending doses in participants with obesity (body mass index (BMI) ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²) with weight-related comorbidities....The Phase I study for ASC36 is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC36 injections following single and multiple ascending doses in participants with obesity (BMI ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²) with weight-related comorbidities."

Trial status • Obesity

Ascletis Pharma…announces today recent submissions of two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity (PRNewswire) - "Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation."

IND • 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 Selects Oral Amylin Receptor Peptide Agonist, ASC36, for Clinical Development (PRNewswire) - "In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once-daily dosing for 7 days. ASC36 tablets also reduced food intake significantly. In a head-to-head diet-induced obese (DIO) rat model, ASC36 demonstrated approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively....Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets for the treatment of obesity in the second quarter of 2026."

IND • 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 Amylin Receptor Agonist, ASC36, for Clinical Development (PRNewswire) - "Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026....In a head-to-head diet-induced obese (DIO) rat study, which is well established as being highly predictive of human efficacy, dosed with equal molar concentrations of ASC36 and petrelintide, ASC36 reduced body weight by 10.01%, compared to 5.25% for petrelintide..."

IND • Preclinical • Obesity