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NCT05500222
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
Conditions: NASH, Cirrhosis, Liver
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 845
Sponsor: Madrigal Pharmaceuticals, Inc.
Location: University of Alabama at Birmingham (UAB) Birmingham Alabama
Summary
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.
Eligibility Criteria
Inclusion Criteria:
* A clinical diagnosis of NASH cirrhosis
* At least 3 metabolic risk factors
* Historical liver biopsy read as consistent with NASH cirrhosis.
* Historical biopsy consistent with NASH with significant fibrosis, now with progression to cirrhosis. Or, no historical biopsy, with a clinical picture of NASH cirrhosis.
* Well-compensated Child-Pugh A (score of 5-6) cirrhosis at Screening and Baseline
* No history of a hepatic decompensation event.
* MRE ≥4.2 obtained during the screening period (if MRE is \
Source: ClinicalTrials.gov (NCT05500222). StuddyBuddy aggregates publicly available trial information.
