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NOT YET RECRUITING
NCT06773221
NA

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

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

195

Start Date

2025-02-05

Completion Date

2028-06-30

Last Updated

2025-01-15

Healthy Volunteers

No

Interventions

DRUG

Chiglitazar 64mg

Chiglitazar 64mg, oral, qd, for 72 weeks

DRUG

Placebo

Placebo, oral, qd, for 72 weeks

Locations (4)

Beijing Ditan Hospital, Capital Medical University

Beijing, China, China

Peking University People's Hospital

Beijing, China, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China, China

Beijing Youan Hospital, Capital Medical University

Beijing, China, China