– ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses.
– ASC30 oral once-daily tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 5 mg, 10 mg, and 20 mg doses. No vomiting was seen in this dose group.
– Data from three different weekly titration schemes in the Phase Ib trial support utilizing a “lower starting dose and slower titration” strategy for a 13-week Phase IIa study design of ASC30 oral once-daily tablet.
HONG KONG, April 22, 2025 /PRNewswire/ — Ascletis Pharma Inc. (HKEX:1672, “Ascletis”) announces today positive topline results of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study (NCT06680440), conducted in the U.S., of ASC30 oral once-daily tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2). The Phase Ib MAD study consisted of three cohorts, each with a different weekly titration scheme, for a total of four-week treatment and one-week follow up. Scheme 1 (mid starting dose, slow titration: 2 mg, 5 mg, 10 mg, and 20 mg); Scheme 2 (mid starting dose, normal titration: 2 mg, 10 mg, 20 mg, and 40 mg); and Scheme 3 (high starting dose, fast titration: 5 mg, 15 mg, 30 mg, and 60 mg). Based on single ascending dose (SAD) data in participants with obesity, Schemes 1 and 2 were designed to investigate tolerability and efficacy. All participants with obesity stayed at the clinical site from day 1 to day 2 and from day 27 to day 29. For other days during the study, participants maintained their habitual eating and physical activity patterns as out-patients.
Mean body weight reductions from baseline for Scheme 1 (mid starting dose, slow titration: 2 mg, 5 mg, 10 mg, and 20 mg) and Scheme 2 (mid starting dose, normal titration: 2 mg, 10 mg, 20 mg, and 40 mg) were 4.3% (n=7, p=0.0002 vs placebo) and 6.3% (n=8, p