The 12-week U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of the once-monthly subcutaneous (SQ) depot formulation (treatment formulation) of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 in 65 participants with obesity or overweight.

-          The ultra-long-acting SQ depot treatment formulation of small molecule ASC30 demonstrated a 46-day observed half-life in participants with obesity in the Phase Ib study, supporting once-monthly administration.

-          Topline data from the 12-week Phase IIa study of ASC30 once-monthly SQ depot treatment formulation are expected in the first quarter of 2026.

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Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the recent completion of enrollment in the U.S. Phase IIa study for its once-monthly subcutaneous (SQ) depot formulation (treatment formulation) of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity (NCT06679959). All 65 participants are obese or overweight with at least one weight-related comorbidity.

The Phase IIa study of ASC30 once-monthly SQ depot treatment formulation is a 12-week, randomized, double-blind, placebo-controlled and multi-center study conducted in the U.S. to evaluate the safety, tolerability and efficacy in participants with obesity (body mass index (BMI) ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m² but < 30 kg/m²) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total of 65 participants. Topline data are expected in the first quarter of 2026.

The ultra-long-acting SQ depot treatment formulation of small molecule ASC30 demonstrated a 46-day observed half-life (as measured by time to 50% C_max) in participants with obesity in the Phase Ib study (NCT06679959), supporting once-monthly administration. ASC30 treatment formulation's terminal half-life was 36 days.

Furthermore, the U.S. Phase Ib single ascending dose (SAD) study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot treatment formulation showed a peak-to-trough ratio of approximately 1.5 to 1. The proprietary SQ depot slow-release treatment formulation of ASC30 was developed from Ascletis' Ultra-Long-Acting Platform (ULAP). Ascletis' ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many peptide drugs and candidates, which limits half-life extension to the half-life of albumin (approximately 20 days).

"Completing enrollment in this study is an important milestone, marking significant progress in our development of this innovative therapy," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "Ascletis' proprietary ultra-long-acting SQ depot treatment formulation of ASC30, with its 46-day observed half-life and favorable peak-to-trough ratio of approximately 1.5 to 1, demonstrated the potential to become a once-monthly treatment option for obesity. We are looking forward to topline data from this Phase IIa study in the first quarter of 2026."

ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management.