China-based Ascletis Pharma Inc. (HKG: 1672) announced the first subject dosing of the ASC47-103 study in the US for its single-dose, ultra-long-acting subcutaneously (SQ) administered ASC47 in combination with semaglutide. The study targets participants with obesity who do not have Type 2 diabetes, marking a significant step in the development of novel treatments for obesity.
Study Design and Objectives
The ASC47-103 study is a randomized, double-blind, placebo-controlled trial designed to assess the safety and preliminary efficacy of single ascending doses (10 mg, 30 mg, and 60 mg) of ASC47 combined with four doses of semaglutide (0.5 mg, once weekly) in people with obesity. This comprehensive approach aims to evaluate the potential benefits of combining ASC47 with an established therapy like semaglutide.
Preclinical Results and Expectations
In a head-to-head diet-induced obese (DIO) mouse model, low-dose ASC47 in combination with semaglutide demonstrated a 56.7% greater reduction in body weight with muscle preservation compared to semaglutide monotherapy. These promising preclinical results set the stage for the clinical evaluation of ASC47’s potential in improving weight management outcomes. Topline results from the ASC47-103 study are expected to be released during the first quarter of this year.-Fineline Info & Tech
