Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05500222 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
A Phase 3 study of Cirrhosis, Liver and NASH, sponsored by Madrigal Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT05500222: Active Phase 3 study of Cirrhosis, Liver and NASH, sponsored by Madrigal Pharmaceuticals.
NCT05500222 is a Phase 3 study of Cirrhosis, Liver and NASH that is active but no longer recruiting, run by Madrigal Pharmaceuticals. The registered enrollment target is 700 participants, above the 222-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (215% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05500222, a Phase 3 study of Cirrhosis, Liver and NASH, is active but no longer recruiting, sponsored by Madrigal Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Resmetirom
Study Locations (20)
Florida
- Hi Tech and Global Research - Coral Gables
- Top Medical Research Inc - Cutler Bay
- Covenant Research - Fort Myers - Fort Myers
- Nature Coast Clinical Research - Inverness - Inverness
- Jacksonville Center for Clinical Research - Jacksonville
- Ocala GI Research DBA Lake Center for Clinical Research - Lady Lake
- Florida Research Institute - Lakewood Rch
California
- Southern California Research Center - Coronado
- University of California, San Francisco-Fresno - Fresno
- Univ. of California San Diego School of Medicine - La Jolla
- Keck School of Medicine of USC - Los Angeles
- California Liver Research Institute - Pasadena
Arizona
- Arizona Liver Health - Chandler - Chandler
- Arizona Liver Health - Peoria - Peoria
- Adobe Clinical Research - Tucson
- Arizona Liver Health - Tucson - Tucson
Arkansas
- Arkansas Diagnostic Center/Liver Wellness Center - Little Rock
- Arkansas Gastroenterology - North Little Rock
Alabama
- University of Alabama at Birmingham (UAB) - Birmingham
Colorado
- South Denver Gastroenterology - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
What the registry record for NCT05500222 still lists
NCT05500222 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 222-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (215% higher).
The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05500222 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05500222 about?
NCT05500222 is a clinical study titled "A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)". 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.
What is the current status of trial NCT05500222?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2022-08-26. Estimated completion is 2027-01.
What conditions does trial NCT05500222 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, NASH.
What interventions are being tested in trial NCT05500222?
The interventions under investigation include: Placebo (DRUG), Resmetirom (DRUG).
Who is sponsoring clinical trial NCT05500222?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05500222 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis, Liver
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05500222's enrollment target sits among peer trials
700 5th of 34 higher than 30 of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
COMPLETED · Phase 3
-
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
COMPLETED · Phase 3
-
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
RECRUITING · Phase 1
-
Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
RECRUITING · Phase 4
-
Measuring Patient Reported Needs in Outpatient Liver Disease Management
RECRUITING
-
Molecular Mechanism of Exercise in Cirrhosis
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00900419 · 700 participants
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
- NCT01804686 · 700 participants · Phase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
- NCT02107989 · 700 participants
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
- NCT02129543 · 700 participants
Immune Reconstitution in Stem Cell Transplant Recipients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI