The combination study is designed to evaluate the safety and preliminary efficacy of a single-dose of ultra-long-acting subcutaneously administered ASC47 in combination with four doses of semaglutide (0.5 mg, once-weekly) in participants with obesity.
As an adipose-targeted,muscle-preserving weight loss drug candidate for the treatment of obesity, ASC47 monotherapy demonstrated a half-life of up to 40 days in a Phase Ib study in participants with obesity.
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.
Topline data from the combination clinical study are expected in the fourth quarter of 2025.
Ascletis Pharma Inc. (HKEX:1672, “Ascletis”) announces that the first participantshave been dosedin the randomized, double-blind, placebo-controlled study (ASC47-103 study) evaluating the safety and preliminary efficacy of single-dose, ultra-long-acting subcutaneously (SQ) administered ASC47 in combination with semaglutide in participants with obesity who do not have Type 2 diabetes. The ASC47-103 study, conducted in the U.S.,consists of three cohorts with single ascending doses (10 mg, 30mg and 60 mg) of ASC47 or volume-matched placebo. Participants in each cohort will also receive four doses of semaglutide (0.5 mg, once weekly) (NCT06972992).
ASC47 is an adipose-targeted, ultra-long-acting SQ injectedthyroid hormone receptor beta(THRB) selective small molecule agonist, discovered and developed in-house at Ascletis. ASC47 possesses unique and differentiated properties to enable adipose targeting, resulting in dose-dependent high drug concentrations in the adipose tissue. ASC47 monotherapy demonstrated a half-life of up to 40 days in a Phase Ib study in participants with obesity. 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 musclepreservation compared to semaglutide monotherapy.
Topline data from the ASC47-103 study are expected in the fourth quarter of 2025.
“To our knowledge, this is the first clinical study combining THRBtargetingmechanismand an incretin drug for obesity,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “We believe data from this combination study will help us design our once-monthly combination study of ASC47 and ASC30 (GLP-1R agonist), both of which have demonstrated a long half-life of 40 days and 36 days, respectively, in participants with obesity.”
About ASC47-103 Study
The ASC47-103 study, conducted in the U.S., is a randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety and preliminary efficacy of single-dose, ultra-long-acting subcutaneously (SQ) administered ASC47 in combination with semaglutide in participants with obesity (body mass index ≥ 30 kg/m2). The ASC47-103 study consists of three cohorts: Cohort 1 participants will receive a single dose of 10 mg ASC47, or volume-matched placebo via SQ injection, and four doses of semaglutide (0.5 mg, once-weekly) via SQ injection. Cohort 2 participants will receive a single dose of 30 mg ASC47, or volume-matched placebo via SQ injection, and four doses of semaglutide (0.5 mg, once-weekly) via SQ injection. Cohort 3 participants will receive a single dose of 60 mg ASC47, or volume-matched placebo via SQ injection, and four doses of semaglutide (0.5 mg, once-weekly) via SQ injection.
About Ascletis Pharma Inc.
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline.
For more information, please visit www.ascletis.com.
Contact:
Peter VozzoICR Healthcare443-231-0505 (U.S.)Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ascletis.comir@ascletis.com
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