Ascletis Pharma has reported promising results from its Phase Ib trial of ASC47, a muscle-preserving weight loss treatment aimed at targeting adipose tissue. The therapy showed a half-life of up to 26 days in volunteers with high cholesterol and up to 40 days in patients with obesity, following a single injection.
ASC47, a subcutaneous therapy, was administered to patients with elevated low-density lipoprotein cholesterol (LDL-C). The Hong Kong-based company now believes the trial’s findings support the possibility of a monthly or twice-monthly dosing regimen for the selective small molecule agonist.
The trial was divided into two parts. The first involved a single ascending dose (SAD) study with three groups of participants who had high LDL-C. Each group received different doses of ASC47: 10mg, 30mg, or 90mg. The second part focused on patients with obesity, who received either a 90mg dose of ASC47 or a placebo. A total of 60 Australian volunteers participated in the trial, with 30 in each part.
The primary goal of the trial was to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ASC47. The results showed significant reductions in LDL-C and total cholesterol (TC) in both cohorts. LDL-C levels dropped by up to 22%, and TC levels were reduced by up to 16% compared to the placebo.
For the obesity group, early signs of weight loss were observed. At day 29, participants experienced a placebo-adjusted mean weight loss of 0.2%, which increased to 1.0% by day 43, and peaked at 1.7% on day 50.
Ascletis explained that the weight loss therapy is designed to help reduce weight gradually while minimizing muscle loss, a common side effect of weight loss. ASC47 is a once-monthly, subcutaneous THRβ selective small molecule agonist that specifically targets fat.
Looking ahead, Ascletis plans to begin a multiple ascending dose (MAD) study of ASC47 for obesity treatment in the second half of 2025. The company also received an Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for a combination study of ASC47 and Novo Nordisk’s semaglutide to treat obesity. The first patient in this study is expected to be dosed by the end of Q2 2025.
Jinzi Jason Wu, CEO of Ascletis, expressed enthusiasm about the data from the Phase Ib trial, stating, “We are excited and encouraged by the data from the ASC47 monotherapy Phase Ib studies in Australia in subjects with and without obesity and by the US IND clearance by the FDA for ASC47 in combination with semaglutide.”
He added, “These data and FDA clearance boost our confidence that ASC47-based monotherapy and combination therapies have clinical potential to reduce body weight and preserve muscle compared to incretin-based drugs alone. We are advancing ASC47 as both a monotherapy and a combination therapy for obesity and other metabolic diseases.”
The announcement comes after Ascletis reported that its oral small molecule glucagon-like peptide 1 receptor agonist (GLP-1RA) achieved a 6.3% reduction in body weight after a 28-day Phase Ib trial.
Meanwhile, Bloom Science’s trial on its weight loss drug, designed to replicate the ketogenic diet, found that 80% of patients maintained weight loss for two weeks after the final dose.
