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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05500222
The ClinicalTrials.gov registry entry for NCT05500222 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 222-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (215% higher). The listed sponsor is Madrigal Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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