Hong Kong; data presented in Milan, Italy, October 2, 2026

Ascletis Pharma Inc. announced key preclinical data for ASC36_35FDC, its fixed-dose combination of the peptide amylin receptor agonist ASC36 and peptide GLP-1R/GIPR dual agonist ASC35, at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting 2026 in Milan. The company reported that ASC36_35FDC demonstrated a stronger weight-loss trend than two comparator combinations in a diet-induced obesity rat model, together with favorable formulation stability and a pharmacokinetic profile supporting the potential for once-monthly to once-quarterly dosing. The findings remain preclinical and will require further evaluation before the potential of the combination can be established in humans.

ASC36_35FDC Demonstrates Strong Weight Reduction

ASC36_35FDC combines two complementary mechanisms: ASC36, an amylin receptor agonist, and ASC35, a peptide GLP-1R/GIPR dual agonist. Ascletis designed the combination to potentially produce synergistic effects on body weight and food intake. In both diet-induced obesity rats and non-human primates, the company reported greater additional reductions in body weight and food intake with ASC36_35FDC compared with ASC35 alone. Ascletis In the DIO rat study, ASC36_35FDC administered at 5 nmol/kg and 8 nmol/kg once every two days produced a 24.8% reduction in body weight by Day 14 under the reported dosing regimen. By comparison, the eloralintide/tirzepatide and MET-233i/tirzepatide combinations produced reductions of 12.5% and 16.8%, respectively. Ascletis reported that the ASC36_35FDC result represented a 98% greater relative reduction than the eloralintide/tirzepatide combination and a 47% greater relative reduction than the MET-233i/tirzepatide combination. Cumulative food intake was also substantially lower in the ASC36_35FDC group.

Long-Acting Profile Could Support Monthly Dosing

One of the notable characteristics reported for ASC36_35FDC is its extended pharmacokinetic profile. In non-human primates, the half-lives of ASC36 and ASC35 within the fixed-dose combination reached approximately 781 hours and 721 hours, respectively. These values correspond to approximately 33 and 30 days and, according to Ascletis, support the potential for once-monthly and possibly once-quarterly subcutaneous administration in humans. Ascletis Long-acting medicines could offer important advantages in chronic weight management by reducing dosing frequency and potentially improving treatment convenience and patient adherence. Ascletis is developing ASC36_35FDC as part of its broader pipeline of long-acting metabolic therapies, including peptide and small-molecule candidates targeting pathways associated with weight management and metabolic disease.

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Stable Formulation Supports Further Development

Beyond weight reduction and pharmacokinetics, Ascletis reported favorable chemical and physical stability for ASC36_35FDC. Under simulated storage conditions of 25°C and 200 rpm for 168 hours, the formulation showed no evidence of fibril-induced aggregation across different concentrations, vehicles, or pH conditions. The company contrasted this finding with cagrilintide, which demonstrated substantial fibril-induced aggregation under the same conditions. Formulation stability is particularly important for peptide-based therapeutics, because aggregation can affect product quality, manufacturing, storage, and administration. Ascletis said the stability findings provide a foundation for further development and potential large-scale manufacturing of ASC36_35FDC.

The candidate was developed using Ascletis’ proprietary AI-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. The company also has a broader metabolic disease pipeline involving GLP-1, GIP, amylin, and other mechanisms.

Source: Ascletis Pharma press release