Shenzhen chipscreen biosciences Co., Ltd. announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome.

Currently, there is only one thyroid receptor ß (TRß) agonist approved worldwide. The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide.

Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good.

The detailed research results will be presented on an upcoming scientific conference or in research article.