ASCLETIS-B (01672) announced that its small molecule GLP-1 receptor (GLP-1R) agonist ASC30, designed for obesity treatment as a monthly subcutaneous depot formulation, has completed subject enrollment in its U.S. Phase IIa study (NCT06679959). A total of 65 subjects, all part of the obesity population or overweight individuals with at least one weight-related comorbidity, have participated. The Phase IIa trial, a 12-week, randomized, double-blind, placebo-controlled, multi-center clinical study conducted in the U.S., aims to evaluate the safety, tolerability, and efficacy of ASC30 in obese subjects (Body Mass Index (BMI) ≥ 30 kg/m2) or overweight subjects with at least one weight-related comorbidity (27 kg/m2 ≤ BMI < 30 kg/m2). The study consists of three cohorts with different dosing levels, totaling 65 participants. Topline data is expected in the first quarter of 2026.

Phase Ib results (NCT06679959) indicated that the observed half-life of the long-acting subcutaneous formulation of ASC30 in obese subjects reached 46 days, supporting a once-monthly administration schedule. The terminal half-life is reported to be 36 days. Furthermore, the U.S. Phase Ib single ascending dose (SAD) study revealed that the peak-to-trough ratio of this long-acting subcutaneous depot formulation, compared to the trough concentration of ASC30 on day 29, is approximately 1.5 to 1. ASCLETIS's proprietary subcutaneous depot release formulation of ASC30 is developed from its ultra-long-acting drug development platform (ULAP), overcoming limitations of albumin-dependent half-life extension techniques currently applied to various peptide medications and candidates, which are constrained by albumin's half-life of around 20 days.

Dr. Jinzi Wu, founder, chairman, and CEO of ASCLETIS, stated that "the completion of subject enrollment in the Phase IIa study is a significant milestone, marking substantial progress in the development of the innovative therapy ASC30." He added, "With its observed half-life of up to 46 days and an excellent peak-to-trough ratio of about 1.5 to 1, our proprietary ASC30 long-acting subcutaneous depot formulation is poised to become a monthly treatment option for obesity. We look forward to obtaining the topline data from this Phase IIa study in the first quarter of 2026." ASC30, self-developed by ASCLETIS, is the first and only small molecule GLP-1R biased agonist that can be administered once daily orally or via subcutaneous injection once a month to quarterly, serving both as a weight loss treatment and a long-term weight maintenance therapy. ASC30 is a new chemical entity (NCE) with U.S. and global compound patent protection, valid until 2044 (excluding patent extension).