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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 \<4.2 and ≥3.7, then an ELF ≥10.25 OR platelet counts \<140K obtained during the screening period is required for eligibility)
Exclusion Criteria:
* Participants with a chronic liver diseases other than NASH cirrhosis, such as primary biliary cholangitis, primary sclerosing cholangitis, Hepatitis B positive, Hepatitis C, history or evidence of current active autoimmune hepatitis, history or evidence of Wilson's disease, history or evidence of alpha-1 -antitrypsin deficiency, history or evidence of genetic hemochromatosis (hereditary, primary), evidence of drug-induced liver disease, as defined on the basis of typical exposure and history, known bile duct obstruction, or suspected or confirmed liver cancer
* Participants with MELD score ≥12 due to liver disease are excluded.
* Participants with a history of hepatic decompensation or impairment are excluded
* Diagnosis of hepatocellular carcinoma (HCC) at Screening or historically
* Liver Imaging Reporting and Data System (LI-RADS) score ≥4 at Screening
* No history of alcohol-related liver disease or history (within 5 years) of excessive alcohol consumption
* Weight gain or loss ≥5% total body weight within 12 weeks prior to randomization
* PEth value of ≥20 ng/mL measured at Screening
* HbA1c \>9.0%
* Platelet counts \<70,000/mm3 at either screening or baseline
* Use of high dose vitamin E (\>400 IU/day) unless stable for ≥6 months prior to randomization
* Use of pioglitazone \>15 mg per day
* Glucagon-like peptide 1 (GLP-1) agonist therapy for diabetes treatment must be a stable dose for at least 12 weeks prior to randomization. GLP-1 agonists for weight loss must be at stable doses for at least 6 months (including body weight change ≥ 5% weight loss in the 12 weeks prior to randomization)
Primary outcome measure(s)
Incidence Of adjudicated Composite Clinical Outcome event — Baseline up to Month 36 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
Trial sites (141)
Facility
City
Region
Status
University of Alabama at Birmingham (UAB)
Birmingham
Alabama
Arizona Liver Health - Chandler
Chandler
Arizona
Arizona Liver Health - Peoria
Peoria
Arizona
Adobe Clinical Research
Tucson
Arizona
Arizona Liver Health - Tucson
Tucson
Arizona
Arkansas Diagnostic Center/Liver Wellness Center
Little Rock
Arkansas
Arkansas Gastroenterology
North Little Rock
Arkansas
Southern California Research Center
Coronado
California
University of California, San Francisco-Fresno
Fresno
California
Univ. of California San Diego School of Medicine
La Jolla
California
Keck School of Medicine of USC
Los Angeles
California
Knowledge Research Center
Orange
California
California Liver Research Institute
Pasadena
California
University of Colorado
Aurora
Colorado
South Denver Gastroenterology
Engelwood
Colorado
Tampa Bay Medical Research
Clearwater
Florida
Hi Tech and Global Research
Coral Gables
Florida
Top Medical Research Inc
Cutler Bay
Florida
Covenant Research - Fort Myers
Fort Myers
Florida
Nature Coast Clinical Research - Inverness
Inverness
Florida
Jacksonville Center for Clinical Research
Jacksonville
Florida
Ocala GI Research DBA Lake Center for Clinical Research
Lady Lake
Florida
Florida Research Institute
Lakewood Rch
Florida
Schiff Center for Liver Diseases/Univ of Miami
Miami
Florida
Sanchez Clinical Research
Miami
Florida
Ocala GI Research
Ocala
Florida
AdventHealth Orlando th Investigational Drug Services
Orlando
Florida
St Johns Center for Clinical Research
Saint Augustine
Florida
Covenant Research
Sarasota
Florida
International Center for Research
Tampa
Florida
Florida Medical Clinic
Zephyrhills
Florida
Summit Clinical Research
Athens
Georgia
Gastrointestinal Specialists of Georgia
Marietta
Georgia
Northwestern University
Chicago
Illinois
Rush University Medical Center
Chicago
Illinois
University of Kansas Medical Center
Kansas City
Kansas
Kansas Medical Clinic - Gastroenterology
Topeka
Kansas
Delta Research Partners - Bastrop
Bastrop
Louisiana
Tandem Clinical Research
Marrero
Louisiana
Tulane University School of Medicine
New Orleans
Louisiana
+ 101 more sites — see the full list on the official registry below.
More Madrigal Pharmaceuticals, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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