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.
This is a multi-national, multicenter, double-blind, randomized, placebo-controlled study in participants with well-compensated NASH cirrhosis. Participants will be randomized 3:1 in a blinded manner to receive 80 mg resmetirom or matching placebo given orally once daily in the morning for the duration of the study (until the required number of Composite Clinical Outcome events are achieved). Composite Clinical Outcome events are defined as any of the following: liver-related and CV mortality, liver transplant, and significant hepatic events, including potential hepatic decompensation events (ascites, hepatic encephalopathy, or gastroesophageal variceal hemorrhage), and confirmed increase of Model for End-stage Liver Disease (MELD) score from \<12 to ≥15. The study comprises an up to 60-day screening period and an approximately 3-year treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
700
Randomized 80 mg
randomized matching placebo
Incidence Of adjudicated Composite Clinical Outcome event
Any event of all-cause mortality, liver transplant, ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage, and confirmed increase of MELD score from \<12 to \>/= 15 due to liver disease
Time frame: Baseline up to Month 36
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University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Arizona Liver Health - Chandler
Chandler, Arizona, United States
Arizona Liver Health - Peoria
Peoria, Arizona, United States
Adobe Clinical Research
Tucson, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Arkansas Diagnostic Center/Liver Wellness Center
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Southern California Research Center
Coronado, California, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Univ. of California San Diego School of Medicine
La Jolla, California, United States
...and 45 more locations