Chinese pharmaceutical company Ascletis Pharma Inc (HKEX:1672) announced on Sunday that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in a new 12-week Phase IIa study in the United States.
This study will assess a once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity.
In the completed US Phase Ib single ascending dose (SAD) study, the ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity, supporting once monthly administration.
Utilising this innovative platform, Ascletis has designed and developed two small molecule SQ compounds for obesity with half-lives of 36 days (ASC30) and 40 days (ASC47) in participants with obesity.
The randomised, double-blind, placebo-controlled and multi-centre Phase IIa study is designed to evaluate the safety, tolerability and efficacy of ASC30 once-monthly SQ depot formulation in obese or overweight participants with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total of approximately 65 participants. Ascletis expects topline data 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 dosed once daily orally and once monthly subcutaneously for the treatment of obesity.
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