Study of Chiglitazar with Vitamin E and Polyene Phosphatidylcholine for Treating Metabolic Dysfunction-Associated Steatohepatitis and Type 2 Diabetes in Adults

What this Trial Is About

This research aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for adults with metabolic dysfunction-associated steatohepatitis MASH and type 2 diabetes mellitus T2DM. MASH, formerly known as non-alcoholic steatohepatitis NASH, is a liver condition linked to metabolic syndrome and presents heightened risks when combined with T2DM. This trial focuses on addressing the unmet need for effective treatments in this specific patient population. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial enrolling 300 adults aged 18 to 75 years with biopsy-confirmed MASH and fibrosis stage 1b or higher. Participants will be randomized to receive either 48 mg of chiglitazar daily or a matching placebo. All participants will also receive background therapy with vitamin E 100 mg three times daily and polyene phosphatidylcholine 456 mg three times daily. Treatment will continue for 72 weeks. Participants will undergo assessments including liver biopsies, Fibroscan examinations, and blood tests at baseline and throughout the study. Researchers will measure the percentage of participants achieving resolution of steatohepatitis without worsening liver fibrosis at week 72 as the primary outcome. Secondary outcomes include liver fibrosis improvement, changes in body mass index, liver stiffness, liver fat content, blood sugar control HbA1c, lipid levels, liver function, and MRI-based liver fat measurements. Safety and metabolic biomarkers will be monitored closely during the trial period.

A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus