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Non-Alcoholic Fatty Liver DiseasePhase 3NCT04951219

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 testing Resmetirom in people with Non-Alcoholic Fatty Liver Disease, run by Madrigal Pharmaceuticals, Inc. at 76 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
Resmetirom
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
810 participants
Where
76 sitesin 2 countries
Study dates
9 Jul 2021to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

76 sites in 2 countries.

76 sites in 2 countries

United States75 sites

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78746

  • Rovia Clinical Research

    Bastrop, Louisiana, 71220

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana, 70809

  • Central Research Associates

    Birmingham, Alabama, 35205

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Arizona Liver Health - Chandler

    Chandler, Arizona, 85224

  • East Valley Family Physicians

    Chandler, Arizona, 85224

  • Chicago Research Center

    Chicago, Illinois, 60602

  • Northwestern Memorial Physicians Group

    Chicago, Illinois, 60611

  • Innovative Clinical Research

    Clarksville, Tennessee, 37040

  • Aventiv Research Columbus

    Columbus, Ohio, 43213

  • The Liver Institute At Methodist Dallas

    Dallas, Texas, 75203

  • Dallas Research Center

    Dallas, Texas, 75234

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Clarity Clinical Research

    East Syracuse, New York, 13057

  • Velocity Clinical Research

    East Syracuse, New York, 13057

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • South Denver Gastroenterology - Swedish Medical Center Office

    Englewood, Colorado, 80113

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates & Endoscopy Center - Flowood

    Flowood, Mississippi, 39232

  • Covenant Research

    Fort Myers, Florida, 33912

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • Gastro One - Germantown Office - Wolf Park Drive

    Germantown, Tennessee, 38138

  • The Institute For Liver Health - Glendale

    Glendale, Arizona, 85306

  • Velocity Clinical Research, Hallandale Beach (MD Clinical)

    Hallandale, Florida, 33009

  • Henderson Research Center

    Henderson, Nevada, 89052

  • Floridian Clinical Research

    Hialeah, Florida, 33016

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Liver Associates of Texas

    Houston, Texas, 77030

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452

  • Southern Therapy and Advanced Research

    Jackson, Mississippi, 39216

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Wasatch Peak Family Practice

    Layton, Utah, 84041

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • National Research Institute - Los Angeles

    Los Angeles, California, 90057

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Awasty Research Network

    Marion, Ohio, 43302

  • Tandem Clinical Research - New Orleans Area Site

    Marrero, Louisiana, 70072

  • Doctor's Hospital at Renaissance

    McAllen, Texas, 78504

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016

  • Lucas Research

    Moorehead City, North Carolina, 28557

  • Diabetes and Endocrinology Consultants

    Morehead City, North Carolina, 28557

  • Salt Lake City Research Center

    Murray, Utah, 84123

  • Mount Sinai Health System

    New York, New York, 10029

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Orlando Research Center

    Orlando, Florida, 32806

  • National Research Institute - Panorama City

    Panorama City, California, 91402

  • Plano Research Center

    Plano, Texas, 75093

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia, 23298

  • Texas Liver Institute/American Research Corporation

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • San Antonio Research Center

    San Antonio, Texas, 78229

  • Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78666

  • Covenant Research

    Sarasota, Florida, 34240

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • The Villages Research Center

    The Villages, Florida, 32162

  • Kansas Medical Clinic - Gastroenterology

    Topeka, Kansas, 66606

  • The Institute For Liver Health - Tucson

    Tucson, Arizona, 85711

  • Adobe Gastroenterology

    Tucson, Arizona, 85712

  • Impact Research Institute

    Waco, Texas, 76710

  • Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center

    Webster, Texas, 77598

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50265

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • San Fernando Valley Health Institute

    West Hills, California, 91307

  • Clinical Trials of America

    West Monroe, Louisiana, 71291

Other trials in United States

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    San Juan

Other trials in Puerto Rico

About this study

Official title: A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, 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)

Being tested
Resmetirom
Keywords
NAFLD, NASH, Hyperlipidemia, Resmetirom, Thyroid hormone receptor beta, Hepatic, Fibrosis, NASH resolution, Thyroid hormone receptor agonist, Cardiovascular, Dyslipidemia, Fatty liver disease, Nonalcoholic steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Hyperlipidemias, Thyroid Hormone Resistance Syndrome, Fibrosis, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResmetiromDrug

    Also called MGL-3196

    Tablet

Study groups in NCT04951219
Study groupRoleWhat they receive
Double-blind 80 mg DailyExperimentalFor patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Receives: Drug: Resmetirom
Double-blind 100 mg DailyExperimentalFor patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Receives: Drug: Resmetirom
Open-labelExperimentalFor patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for up to an additional 66 months (ie, 52 weeks in MGL-3196-14 and up to 66 months in MGL-3196-18).
Receives: Drug: Resmetirom
Open-Label 80 mgExperimentalFor patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for up to 66 months.
Receives: Drug: Resmetirom
Open Label 100 mgExperimentalFor patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
Receives: Drug: Resmetirom
Open-Label 40 mgExperimentalFor NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for up to 66 months.
Receives: Drug: Resmetirom

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of once daily, oral administration of resmetirom on the incidence of adverse events.

    Measured: 52 weeks

Secondary outcomes (3)

  1. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline

    Measured: 16 weeks

  2. Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline

    Measured: 52 weeks

  3. Percent change in LDL-C from baseline

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start9 Jul 2021
  3. Primary completionMar 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
810 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951219
Sponsor's protocol ID
MGL-3196-18
Status last verified
May 2026
First submitted
18 Jun 2021
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.

    PubMed 37786277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Resmetirom in people with Non-Alcoholic Fatty Liver Disease, run by Madrigal Pharmaceuticals, Inc. at 76 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of once daily, oral administration of resmetirom on the incidence of adverse events. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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