MedTrace Logo

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

NCT06773221 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2025-01-15

No results posted yet for this study

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

DRUG

Chiglitazar 64mg

Chiglitazar 64mg, oral, qd, for 72 weeks

DRUG

Placebo

Placebo, oral, qd, for 72 weeks

Sponsors & Collaborators

  • Beijing Ditan Hospital

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Beijing YouAn Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773221 on ClinicalTrials.gov