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 the UK
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 the UK