Chinese pharmaceutical company CureGene announced on Friday that the first subject has been dosed in its Phase I clinical trial of CG-0416, a novel oral liver-targeting THR-beta agonist developed in-house, in Australia.

The company said that enrolment of participants in the trial is progressing smoothly.

CG-0416 is based on CureGene's proprietary prodrug platform, incorporating precise design and structural optimisation to achieve several key differentiators, including liver-targeting delivery, improved metabolic parameters, fat loss with muscle preservation, non-CYP metabolism pathway, and high oral bioavailability. These characteristics position CG-0416 as a promising oral therapy for chronic metabolic diseases, including obesity and metabolic dysfunction-associated steatohepatitis (MASH), CureGene said.

Preclinical data demonstrated that CG-0416 potently activates lipid metabolism in the liver, markedly reduces liver fat accumulation, and consequently ameliorates inflammation and fibrosis. As a monotherapy, CG-0416 has a weight-loss efficacy comparable to that of mainstream GLP-1 receptor agonists but shows minimum muscle loss. When combined with GLP-1 RAs, CG-0416 exhibits a strong synergistic effect for reducing weight and improving metabolic parameters.

The FIH Phase I trial in Australia is a randomised, double-blind, placebo-controlled study in healthy participants, designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CG-0416 following single and multiple ascending doses.