Chinese pharmaceutical company Ascletis Pharma Inc (HKEX: 1672) announced on Monday that that all 28 participants have been dosed in the randomised, double-blind, placebo-controlled study 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.
Conducted in the United States, the study 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).
ASC47 is an adipose-targeted, ultra-long-acting SQ injected thyroid hormone receptor beta (THR beta) selective small molecule agonist, discovered and developed in-house at Ascletis. According to the company, 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). 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 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 this combination study of ASC47 with semaglutide are expected in the fourth quarter of 2025.
Amgen reports results of Phase 2 MariTide obesity study
European Medicines Agency recommends approval of Alvotech's biosimilar to Eylea
Gan & Lee presents trial results for novel diabetes therapies at ADA's 85th Scientific Sessions
TME Pharma and SERI partner to advance NOX-E36 in ophthalmology through option framework agreement
Innovent reports first participant dosed in new Phase 3 trial of mazdutide in China
Vivoryon Therapeutics presents positive meta-analysis data for varoglutamstat
Camurus and Lilly agree licensing deal for FluidCrystal incretins
Genprex signs new research agreement with University of Pittsburgh to advance diabetes gene therapy