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ACTIVE NOT RECRUITING 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)

NCT05500222 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 700 participants
Start Date 2022-08-26
Est. Completion 2027-01
Phase Phase 3

Sponsor

Madrigal Pharmaceuticals

6 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Madrigal Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05500222 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05500222?

The interventions under investigation include: Placebo (DRUG), Resmetirom (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05500222?

This trial is sponsored by Madrigal Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial