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NCT04951219 · ClinicalTrials.gov registry record · 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)

A Phase 3 study of Non-alcoholic Fatty Liver Disease, sponsored by Madrigal Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
1,000
Enrollment target
20
Study locations

NCT04951219 is a Phase 3 study of Non-alcoholic Fatty Liver Disease that is active but no longer recruiting, run by Madrigal Pharmaceuticals. The registered enrollment target is 1,000 participants, above the 170-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (488% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT04951219, a Phase 3 study of Non-alcoholic Fatty Liver Disease, is active but no longer recruiting, sponsored by Madrigal Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
20
Study locations

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

17 total trials

What the Registry Record Tells You About NCT04951219

The ClinicalTrials.gov registry entry for NCT04951219 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 170-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (488% higher). The listed sponsor is Madrigal Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.

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.

NCT04951219 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Arizona, Florida.

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.

What interventions are being tested in trial NCT04951219?

The interventions under investigation include: Resmetirom (DRUG).

Who is sponsoring clinical trial NCT04951219?

This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.