drugset / Trial / NCT06773221
The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis
Not yet recruiting
195 enrolled
Beijing Friendship Hospital
Beijing Ditan Hospital · collabBeijing YouAn Hospital · collabPeking University People's Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-02-05
- Primary completion
- 2028-01-31
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chiglitazar | Unknown | 64 mg | Oral |