Ascletis Pharma Inc. (ASCLF.PK,1672.HK) announced that ASC47, a muscle-preserving weight loss drug candidate, demonstrated up to a 56.2% greater relative reduction in body weight on Day 29 when combined with semaglutide, compared to semaglutide monotherapy (placebo plus semaglutide) in participants with obesity.
The combination also showed significantly improved gastrointestinal (GI) tolerability. Vomiting occurred in only 6.7% of participants receiving ASC47 with semaglutide, versus 57.1% in the semaglutide monotherapy group.
Additionally, the ultra-long-acting subcutaneous (SQ) depot formulation of ASC47 exhibited a lower rebound effect after treatment discontinuation, supporting its potential as a once-monthly maintenance therapy.
ASC47-103 study, conducted in the U.S., was a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of a single-dose, ultra-long-acting subcutaneously administered ASC47 in combination with four weekly doses of 0.5 mg semaglutide in participants with obesity, compared to volume-matched placebo in combination with four weekly doses of 0.5 mg semaglutide. The treatment duration was four weeks and the follow-up period was six weeks.
The study, conducted in the U.S., enrolled 28 participants with obesity. Study objectives included evaluations of safety, tolerability, pharmacokinetics, assessment of weight losses of three different single doses (10 mg, 30 mg and 60 mg) of ASC47 in combination with four weekly doses of 0.5 mg semaglutide. The effect on fat and lean mass was not an objective of this study given the short treatment duration (28 days).
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