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ACTIVE NOT RECRUITING Phase 3

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

NCT04951219 · View on ClinicalTrials.gov ↗

Study Summary

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

Interventions

  • DRUG Resmetirom

Study Locations (20)

California

  • Fresno Clinical Research Center — Fresno
  • National Research Institute - Huntington Park — Huntington Park
  • Ruane Clinical Research Group — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • National Research Institute - Los Angeles — Los Angeles
  • National Research Institute - Panorama City — Panorama City
  • San Fernando Valley Health Institute — West Hills

Arizona

  • Arizona Liver Health - Chandler — Chandler
  • East Valley Family Physicians — Chandler
  • The Institute For Liver Health - Glendale — Glendale
  • The Institute For Liver Health - Tucson — Tucson
  • Adobe Gastroenterology — Tucson

Florida

  • Excel Medical Clinical Trials — Boca Raton
  • Covenant Research — Fort Myers
  • Velocity Clinical Research, Hallandale Beach (MD Clinical) — Hallandale
  • Floridian Clinical Research — Hialeah
  • Nature Coast Clinical Research - Inverness — Inverness

Alabama

  • Central Research Associates — Birmingham

Arkansas

  • Arkansas Gastroenterology — North Little Rock

Colorado

  • South Denver Gastroenterology - Swedish Medical Center Office — Englewood

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2021-07-09
Est. Completion 2026-04
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 NCT04951219

The ClinicalTrials.gov registry entry for NCT04951219 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 1,000 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 1 condition, with Non-Alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 1 intervention — of which Resmetirom 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: NCT04951219 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Florida. 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 NCT04951219 about?

NCT04951219 is a clinical study titled "A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)". A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

What is the current status of trial NCT04951219?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2021-07-09. Estimated completion is 2026-04.

What conditions does trial NCT04951219 study?

This clinical trial studies the following conditions: Non-Alcoholic Fatty Liver Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04951219?

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

Who is sponsoring clinical trial NCT04951219?

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 NCT04951219 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