- The combination study, conducted in the U.S., is designed to evaluate the safety, tolerability and preliminary efficacy at Day 29 of a single-dose of ultra-long-acting subcutaneously administered ASC47 (half-life up to 40 days) in combination with four doses of semaglutide (0.5 mg, once weekly) in 28 participants with obesity.
- Initiated in May 2025, all 28 participants were enrolled in less than two months.
- Topline data are expected in the fourth quarter of 2025.
HONG KONG, July 15, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that all the 28 participants have recently been dosed in the randomized, double-blind, placebo-controlled study (ASC47-103 study, NCT06972992) evaluating the safety, tolerability and preliminary efficacy at Day 29 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 total time to enroll all the 28 participants was less than two months. The study, conducted in the U.S., consists of three cohorts with single ascending doses (10 mg, 30 mg and 60 mg) of ASC47 or volume-matched placebo. Participants in each cohort also receive four doses of semaglutide (0.5 mg, once weekly).
"The rapid pace of enrollment underscores the interest in developing new treatment options for obesity and the potential advantages combination therapies may offer," said Jinzi J. Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "We remain on track to provide topline data from the trial in the fourth quarter of 2025."
ASC47 is an adipose-targeted, ultra-long-acting SQ injected thyroid hormone receptor beta (THRβ) 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. As demonstrated in diet-induced obese (DIO) mouse model, high drug concentrations of ASC47 in the adipose tissue reduced significantly more fat mass than semaglutide (63.5% vs 39.6%, p=0.007) and tirzepatide (68.0% vs 50.4%, p=0.01) (Press Release). ASC47 monotherapy demonstrated a half-life of up to 40 days in a Phase Ib study (NCT06427590) in participants with obesity (Press Release). In a head-to-head 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 (Press Release).
Topline data from this combination study of ASC47 with semaglutide are expected in the fourth quarter of 2025.
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, tolerability 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 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 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 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 Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact：
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com