A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
Condition(s) studied
Investigational drug(s) / intervention(s)
Resmetirom: Randomized 80 mg
Placebo: randomized matching placebo
Study 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
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 France
Other trials for the same condition
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.
View NCT05500222 on ClinicalTrials.gov ↗ ← All trials in France