ASC36_35 FDC / 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' ASC36_35FDC Demonstrated Potential for Once-Monthly to Once-Quarterly Dosing and Robust Weight-Loss in Preclinical Studies Presented at EASD 2026 (PRNewswire) - "In the DIO rat model, ASC36_35FDC administered at 5 nmol/kg_8 nmol/kg once every two days for a total of seven doses demonstrated substantial weight-loss. On Day 14, under the same dosing regimen, body weight decreased by 12.5% with the eloralintide/tirzepatide co-formulation, 16.8% with the MET-233i/tirzepatide co-formulation, and 24.8% with ASC36_35FDC, a 98% and 47% greater relative reduction in body weight, respectively."

Preclinical • 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 that preclinical data of ASC36_35 FDC, a once-monthly injection co-formulation of ASC36, a peptide amylin receptor agonist, and ASC35, a peptide GLP-1R/GIPR agonist, for the treatment of obesity, will be presented in a short oral discussion at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting (PRNewswire) - "Fixed-dose combination of ASC36 and ASC35 (ASC36_35 FDC) demonstrated superior weight loss compared to eloralintide in combination with tirzepatide in a diet-induced obese (DIO) animal model."

Preclinical • 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