ASCLETIS-B (01672) announced that on Day 29, the weight loss candidate drug ASC47 combined with semaglutide demonstrated up to 56.2% relative improvement in weight loss efficacy compared to placebo combined with semaglutide (semaglutide monotherapy) in obese subjects with body mass index ≥30kg/m².

The ASC47-103 study (NCT06972992) is a randomized, double-blind, placebo-controlled study conducted in the United States, designed to evaluate the safety, tolerability, and efficacy of ultra-long-acting subcutaneous ASC47 single-dose administration combined with semaglutide (0.5mg, once weekly for four doses) compared to volume-matched placebo combined with semaglutide (0.5mg, once weekly for four doses) in obese subjects. The treatment period was 4 weeks, with a 6-week follow-up period.

The study was conducted in the United States and enrolled a total of 28 obese subjects. Study objectives included safety, tolerability, pharmacokinetics, and weight loss efficacy evaluation of three different single doses of ASC47 (10mg, 30mg, and 60mg) combined with semaglutide (0.5mg, once weekly for four doses). Due to the short treatment cycle (28 days), the study objectives did not include ASC47's effects on fat mass and muscle mass.

"As the first study to evaluate the combination of adipose-targeted THRβ agonist with incretin drugs in obese subjects, we are very pleased to see that the adipose-targeted THRβ agonist ASC47 combined with incretin treatment produced significant synergistic weight loss efficacy, with relative improvement in weight loss effect up to 56.2%, and substantially improved gastrointestinal tolerability," said Dr. Wu Jinzi, founder, chairman and CEO of ASCLETIS-B. "This study provides important proof-of-concept data that will serve as a key foundation for our subsequent Phase IIb combination therapy study designs for various metabolic diseases including obesity and metabolic dysfunction-associated steatohepatitis (MASH)."