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New pill shows promise for fatty liver in major trial

NCT ID NCT04951219

Disease control Sponsor: Madrigal Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a daily pill called resmetirom in people with non-alcoholic fatty liver disease (NAFLD). The goal is to see if it safely reduces liver fat and cholesterol over 52 weeks. About 810 adults who completed earlier related studies are taking part. This is a long-term treatment approach, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

810 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent. * For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results: * NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3 * NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH) * Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD \<12, albumin ≥3.2, and bilirubin \<2 * For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score \<8) NASH cirrhosis (including minimal decompensation) and MELD \<15 unless MELD \>=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE . Exclusion Criteria: * A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1. * Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study. * Chronic liver diseases * Has an active autoimmune disease * Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.

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Conditions

The condition(s) this trial relates to.

Dyslipidemias Fibrosis hyperlipidemia metabolic dysfunction-associated steatotic liver disease thyroid hormone resistance syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-alcoholic fatty liver disease

Contacts and locations

Locations

  • Adobe Gastroenterology

    Tucson, Arizona, 85712, United States

  • Arizona Liver Health - Chandler

    Chandler, Arizona, 85224, United States

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117, United States

  • Aventiv Research Columbus

    Columbus, Ohio, 43213, United States

  • Awasty Research Network

    Marion, Ohio, 43302, United States

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Central Research Associates

    Birmingham, Alabama, 35205, United States

  • Chicago Research Center

    Chicago, Illinois, 60602, United States

  • Clarity Clinical Research

    East Syracuse, New York, 13057, United States

  • Clinical Trials of America

    West Monroe, Louisiana, 71291, United States

  • Covenant Research

    Fort Myers, Florida, 33912, United States

  • Covenant Research

    Sarasota, Florida, 34240, United States

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304, United States

  • Dallas Research Center

    Dallas, Texas, 75234, United States

  • Diabetes and Endocrinology Consultants

    Morehead City, North Carolina, 28557, United States

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana, 70809, United States

  • Doctor's Hospital at Renaissance

    McAllen, Texas, 78504, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • East Valley Family Physicians

    Chandler, Arizona, 85224, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434, United States

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Floridian Clinical Research

    Hialeah, Florida, 33016, United States

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Fresno Clinical Research Center

    Fresno, California, 93720, United States

  • Fundacion de Investigacion de Diego

    San Juan, Puerto Rico

  • Gastro One - Germantown Office - Wolf Park Drive

    Germantown, Tennessee, 38138, United States

  • Gastrointestinal Associates & Endoscopy Center - Flowood

    Flowood, Mississippi, 39232, United States

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060, United States

  • Henderson Research Center

    Henderson, Nevada, 89052, United States

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Innovative Clinical Research

    Clarksville, Tennessee, 37040, United States

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50265, United States

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Kansas Medical Clinic - Gastroenterology

    Topeka, Kansas, 66606, United States

  • L-MARC Research Center

    Louisville, Kentucky, 40213, United States

  • Liver Associates of Texas

    Houston, Texas, 77030, United States

  • Liver Center of Texas

    Dallas, Texas, 75234, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Lucas Research

    Moorehead City, North Carolina, 28557, United States

  • Mount Sinai Health System

    New York, New York, 10029, United States

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294, United States

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255, United States

  • National Research Institute - Los Angeles

    Los Angeles, California, 90057, United States

  • National Research Institute - Panorama City

    Panorama City, California, 91402, United States

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452, United States

  • Northwestern Memorial Physicians Group

    Chicago, Illinois, 60611, United States

  • Orlando Research Center

    Orlando, Florida, 32806, United States

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78746, United States

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229, United States

  • Plano Research Center

    Plano, Texas, 75093, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Rovia Clinical Research

    Bastrop, Louisiana, 71220, United States

  • Ruane Clinical Research Group

    Los Angeles, California, 90036, United States

  • Salt Lake City Research Center

    Murray, Utah, 84123, United States

  • San Antonio Research Center

    San Antonio, Texas, 78229, United States

  • San Fernando Valley Health Institute

    West Hills, California, 91307, United States

  • South Denver Gastroenterology - Swedish Medical Center Office

    Englewood, Colorado, 80113, United States

  • South Texas Research Institute

    Edinburg, Texas, 78539, United States

  • Southern Therapy and Advanced Research

    Jackson, Mississippi, 39216, United States

  • Tandem Clinical Research - New Orleans Area Site

    Marrero, Louisiana, 70072, United States

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104, United States

  • Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center

    Webster, Texas, 77598, United States

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78666, United States

  • Texas Liver Institute/American Research Corporation

    San Antonio, Texas, 78215, United States

  • The Institute For Liver Health - Glendale

    Glendale, Arizona, 85306, United States

  • The Institute For Liver Health - Tucson

    Tucson, Arizona, 85711, United States

  • The Liver Institute At Methodist Dallas

    Dallas, Texas, 75203, United States

  • The Villages Research Center

    The Villages, Florida, 32162, United States

  • Velocity Clinical Research

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research, Hallandale Beach (MD Clinical)

    Hallandale, Florida, 33009, United States

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia, 23298, United States

  • Wasatch Peak Family Practice

    Layton, Utah, 84041, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.