NCT06773221

The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis

A Key Therapeutic System for Reversing MAFLD-related Cirrhosis: a Randomized Double-blind Controlled Trial on the Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.

Conditions

• Metabolic Dysfunction Associated Fatty Liver Disease
• Compensated Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Chiglitazar 64mg	Chiglitazar 64mg, oral, qd, for 72 weeks
DRUG	Placebo	Placebo, oral, qd, for 72 weeks

Timeline

• Start date: 2025-02-05
• Primary completion: 2028-01-31
• Completion: 2028-06-30
• First posted: 2025-01-14
• Last updated: 2025-01-15

Locations

4 sites across 1 country: China