Business
Ascletis Announces First Participants Dosed in a U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity
Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces that the first participants have been dosed in 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, 30 mg
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"- 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.","length":253,"tagName":"p"},{"type":"text","content":"- 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. ","length":215,"tagName":"p"},{"type":"text","content":"- 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. ","length":225,"tagName":"p"},{"type":"text","content":"- Topline data from the combination clinical study are expected in the fourth quarter of 2025.","length":94,"tagName":"p"},{"type":"text","content":"HONG KONG, May 20, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces that the first participants have been dosed in 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, 30 mg 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).","length":726,"tagName":"p"},{"type":"text","content":"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. 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...