AzTrials
AzTrials

NASH - Nonalcoholic SteatohepatitisPhase 3MAESTRO-NASHNCT03900429

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

A Phase 3 study testing MGL-3196 and Liver Biopsy in people with NASH - Nonalcoholic Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 247 sites in 16 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 double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NASH - Nonalcoholic Steatohepatitis
What is being tested?
MGL-3196 and Liver Biopsy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,759 participants
Where
247 sitesin 16 countries
Study dates
28 Mar 2019to Jan 2028
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

  • Must be willing to participate in the study and provide written informed consent.
  • Male and female adults ≥ 18 years of age.
  • Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NASH liver fibrosis:
  • Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9
  • FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
  • Historical liver biopsy obtained <2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH based on existing pathology review, with no significant change in body weight >5% or medication that might affect NAS or fibrosis stage.
Show all 11Show fewer
  • MRI-PDFF fat fraction ≥8% obtained during the screening period
  • Biopsy-proven NASH (baseline liver biopsy) based on a liver biopsy obtained ≤6 months before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A/1C, 1B, 2, or 3 on liver biopsy and NAS of ≥4 with a score of at least 1 in each of the following NAS components:
  • Steatosis (scored 0 to 3)
  • Ballooning degeneration (scored 0 to 2)
  • Lobular inflammation (scored 0 to 3)

Who cannot join

  • History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
  • Regular use of drugs historically associated with NAFLD
  • Thyroid diseases:
  • Active hyperthyroidism.
  • Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
  • Patients who have had a thyroidectomy and are on replacement thyroxine doses >75 µg per day are allowed.
Show all 20Show fewer
  • History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
  • Recent significant weight gain or loss
  • HbA1c ≥ 9.0%.
  • Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
  • Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
  • Diagnosis of hepatocellular carcinoma (HCC).
  • MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
  • Hepatic decompensation
  • Chronic liver diseases other than NASH
  • Active autoimmune disease
  • Serum ALT > 250 U/L.
  • Active, serious medical disease with a likely life expectancy < 2 years.
  • Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
  • 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

247 sites in 16 countries.

247 sites in 16 countries

United States90 sites

  • Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • South Texas Research Institute - Brownsville

    Brownsville, Texas, 78520

  • East Valley Family Physicians

    Chandler, Arizona, 85224

  • The Institute for Liver Health - Chandler

    Chandler, Arizona, 85224

  • University of North Carolina Medical Center - Chapel Hill

    Charlotte, North Carolina, 27599

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Clinical Research - Chicago

    Chicago, Illinois, 60602

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • Premier Medical Group - Clarksville

    Clarksville, Tennessee, 37040

  • Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Aventiv Research - Columbus

    Columbus, Ohio, 43213

  • Dallas Research Center

    Dallas, Texas, 75234

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas, 75234

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75234

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • South Denver Gastroenterology - Swedish Medical Center Office

    Englewood, Colorado, 80113

  • University of Kansas Medical Center Research Institute

    Fairway, Kansas, 66205

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates and Endoscopy Center - Madison

    Flowood, Mississippi, 39232

  • Covenant Metabolic Specialists - Fort Myers

    Fort Myers, Florida, 33912

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Texas Digestive Disease Consultants - Fort Worth

    Fort Worth, Texas, 76104

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Gastro One - Germantown - Centre Oak Way

    Germantown, Tennessee, 38138

  • The Institute for Liver Health - Glendale

    Glendale, Arizona, 85306

  • Clinical Research US - Henderson

    Henderson, Nevada, 89052

  • Associates in Gastroenterology

    Hermitage, Tennessee, 37076

  • Liver Associates of Texas

    Houston, Texas, 77030

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Southern Therapy and Advanced Research

    Jackson, Mississippi, 39216

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • St. Luke's Hospital Of Kansas City

    Kansas City, Missouri, 64111

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Gastrointestinal Associates - Knoxville

    Knoxville, Tennessee, 37909

  • University of California San Diego

    La Jolla, California, 92037

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Wasatch Peak Family Practice

    Layton, Utah, 84041

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • National Research Institute - Los Angeles

    Los Angeles, California, 90057

  • Ruane Clinical Research

    Los Angeles, California, 90057

  • GI Specialists of Georgia

    Marietta, Georgia, 30060

  • Awasty Research Network

    Marion, Ohio, 43302

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Doctor's Hospital at Renaissance

    McAllen, Texas, 78504

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • University of Miami

    Miami, Florida, 33136

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Salt Lake City Research Center

    Murray, Utah, 84123

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Bioclinica Research - Orlando

    Orlando, Florida, 32806

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • National Research Institute - Panorama City

    Panorama City, California, 91402

  • Plano Research Center

    Plano, Texas, 75093

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Alliance Clinical Research

    Poway, California, 92064

  • Bon Secours St. Mary's Hospital of Richmond

    Richmond, Virginia, 23226

  • Hunter Holmes McGuire Veterans Administration Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23249

  • Pinnacle Clinical Research - Austin

    Rollingwood, Texas, 78746

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • San Antonio Research Center

    San Antonio, Texas, 78229

  • The Texas Liver Institute

    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

  • Saint Louis University

    St Louis, Missouri, 63104

  • Bioclinica Research - The Villages

    The Villages, Florida, 32162

  • Kansas Medical Clinic - Gastroenterology

    Topeka, Kansas, 66606

  • Adobe Gastroenterology

    Tucson, Arizona, 85712

  • The Institute for Liver Health - Tucson

    Tucson, Arizona, 85712

  • San Fernando Valley Health Institute

    Van Nuys, California, 91405

  • Impact Research Institute

    Waco, Texas, 76710

  • Texas Digestive Disease Consultants - Bay Area Gastroenterology

    Webster, Texas, 77598

  • Clinical Trials of America

    West Monroe, Louisiana, 71291

Other trials in United States

United Kingdom23 sites

  • Belfast Health and Social Care Trust

    Belfast, Northern Ireland

  • Midlands Clinical Research Centre

    Birmingham, England

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England

  • The Wales Clinic

    Cardiff, Wales

  • Lancashire Clinical Research Centre

    Chorley, England

  • North Teesside Clinical Research Centre

    Hardwick, England

  • The Hexham Clinic

    Hexham, Northumberland, England

  • Merseyside Clinical Research Centre

    Liverpool, England

  • Aintree University Hospitals NHS Foundation Trust

    Liverpool

  • Barts Health NHS Trust

    London, England

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England

  • Imperial College Healthcare NHS Trust

    London, England

  • Royal Free London NHS Foundation Trust

    London, England

  • Saint George's University Hospitals NHS Foundation Trust

    London

  • Manchester Clinical Research Centre

    Manchester, England

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, England

  • Norfolk and Norwich University Hospital

    Norwich, England

  • Nottingham University Hospitals NHS Trust

    Nottingham, England

  • Plymouth Hospitals NHS Trust

    Plymouth

  • Portsmouth Hospitals NHS Trust

    Portsmouth

  • Thames Valley Dedicated Research Centre

    Reading, England

  • Abertawe Bro Morgannwg University Health Board

    Swansea, Wales

Other trials in United Kingdom

France19 sites

  • Centre Hospitalier Universitaire Amiens-Picardie

    Amiens

  • Center Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region

  • Hôpital Jean-Minjoz

    Besançon, Franche-Comte

  • Hôpital Avicenne

    Bobigny, Île-de-France Region

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Auvergne

  • Hôpital Beaujon

    Clichy

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, Île-de-France Region

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, Hauts-de-France

  • Hôpital Dupuytren

    Limoges, Limousin

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, Languedoc-Roussillon

  • Centre Hospitalier Universitaire de Nice Hôpital l'Archet

    Nice, Provence-Alpes-Côte d'Azur Region

  • Hôpital Universitaire Pitié Salpêtrière

    Paris

  • Assistance Publique-Hôpitaux de Paris Hôpital Cochin

    Paris, Île-de-France Region

  • Centre Hospitalier Universitaire de Rennes

    Rennes, Brittany Region

  • Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre

    Strasbourg, Alsace

  • Nouvel Hôpital Civil

    Strasbourg, Alsace

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil

    Toulouse, Midi-Pyrenees

  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy

Other trials in France

Australia14 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Saint Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Washington, 6009

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Mater Misericordiae

    South Brisbane, Queensland, 4101

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Germany13 sites

  • Berlin Clinical Research Center

    Berlin

  • Charité Universitätsmedizin Berlin - Campus Mitte

    Berlin

  • Charité Universitätsmedizin Berlin

    Berlin

  • EPIMED

    Berlin

  • Zentrum für Infektiologie Berlin Prenzlauer Berg

    Berlin

  • Frankfurt Clinical Research Center

    Frankfurt am Main

  • Universitätsklinikum Frankfurt

    Frankfurt am Main

  • Universitätsklinikum des Saarlandes

    Homburg

  • EUGASTRO

    Leipzig

  • Leipzig Research Center

    Leipzig

  • SIBAmed Studienzentrum

    Leipzig

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Italy12 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo

  • Azienda Ospedaliero - Universitaria Careggi

    Florence

  • Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

    Messina, Messina

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milano

  • Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

    Milan

  • Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

    Novara, Novara

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, Palermo

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

    Palermo

  • Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

    Pisa, 56124

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Roma

  • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

    Roma

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

Other trials in Italy

Spain12 sites

  • Complejo Hospitalario Torrecárdenas

    Almería

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona

  • Hospital del Mar - Parc de Salut Mar

    Barcelona

  • Hospital Universitari Vall d'Hebrón

    Barcelona

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Ramón Y Cajal

    Madrid

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid

  • Complejo Hospitalario de Pontevedra

    Pontevedra

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Universitario Virgen del Rocio

    Seville

  • Consorci Hospital General Universitari de València

    Valencia

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia

Other trials in Spain

Belgium11 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital

  • Hôpital Erasme

    Brussels, Brussels Capital

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerpen

  • Ziekenhuis Oost-Limburg'

    Genk, Limburg

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaanderen

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen

  • Centre Hospitalier Universitaire Brugmann

    Laken

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant

  • Universitair Ziekenhuis Leuven

    Leuven

  • AZ Delta Campus Wilgenstraat

    Roeselare, West-Vlaanderen

Other trials in Belgium

Israel11 sites

  • Emek Medical Center

    Afula

  • Soroka University Medical Center

    Beersheba

  • Rambam Health Care Campus - Rambam Medical Center

    Haifa

  • The Lady Davis Carmel Medical Center

    Haifa

  • Hadassah University Hospital Ein Kerem

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Western Galilee Hospital-Nahariya

    Nahariya

  • Holy Family Hospital

    Nazareth

  • Rabin Medical Center

    Petah Tikva

  • The Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Canada10 sites

  • LMC/ Manna Research - Brampton

    Brampton, Ontario

  • William Osler Health System

    Brampton, Ontario

  • South Shore Medical Arts

    Bridgewater, Nova Scotia

  • University of Calgary Liver Unit

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

  • McMaster University

    Hamilton, Ontario

  • Toronto General Hospital - Clinical Trials Pharmacy

    Toronto, Ontario

  • Toronto Liver Center

    Toronto, Ontario

  • Lair Centre

    Vancouver, V5Z 1J4

  • GI Research Institute

    Vancouver

Other trials in Canada

Poland9 sites

  • Polska Oddział w Częstochowie

    Częstochowa

  • Polska Oddział w Gdansk

    Gdansk

  • Polska Oddział w Gdyni

    Gdynia

  • Polska Oddział w Katowicach

    Katowice

  • Polska Oddział w Łodz

    Lodz

  • Polska Oddział w Poznaniu

    Poznan

  • Centrum Medyczne Pratia Poznan

    Skórzewo, 60-185

  • Polska Oddział w Warszawie

    Warsaw

  • Polska Oddział w Wrocław

    Wroclaw

Other trials in Poland

Austria7 sites

  • Klinikum Klagenfurt Am Wörthersee

    Klagenfurt, Carinthia

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, Upper Austria

  • Landesklinik St. Veit

    Salzburg

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • Krankenanstalt Rudolfstiftung

    Vienna, State of Vienna

  • Medizinische Universität Wien

    Vienna

  • Klinikum Wels-Grieskirchen

    Wels

Other trials in Austria

Hungary7 sites

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    Békéscsaba, Bekes County

  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

    Budapest, Budapest

  • Magyarország Research Center

    Budapest, Budapest

  • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

    Debrecen, Hajdú-Bihar

  • Magyarország Research Center

    Debrecen, Hajdú-Bihar

  • Magyarország Egészségügyi Szolgáltató - Gyula

    Gyula, Bekes County

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

    Nyíregyháza, Szabolcs-Szatmár-Bereg

Other trials in Hungary

Mexico5 sites

  • JM Research

    Cuernavaca, Morelos, 62290

  • Centro Integral en Reumatología

    Guadalajara, Jalisco, 44160

  • Centro Mexicano de Desarrollo de Estudios Clínicos

    Mexico City, Mexico City, 06100

  • Centro de Investigacion y Gastroenterologia

    Mexico City, Mexico City, 06700

  • Investigaciones Médicas Cisneros

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Switzerland3 sites

  • Universitatsspital Bern

    Bern

  • Fondazione Epatocentro Ticino

    Lugano

  • Universitatsspital Zurich

    Zurich

Other trials in Switzerland

Puerto Rico1 site

  • Fundación De Investigación De Diego

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Read the detailed description

Primary and secondary endpoint population at Week 52 will be at least 900 patients, more than half fibrosis score 3 (F3), the remainder fibrosis score 2 (F2) and <10% fibrosis score F1B (F1B) based on final liver biopsy baseline fibrosis score.

Being tested
MGL-3196, Placebo, Liver Biopsy
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

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

  • MGL-3196Drug

    Also called Resmetirom

    Tablet

  • PlaceboDrug

    Matching Tablets

  • Liver BiopsyProcedure or surgery

    A procedure in which a needle is inserted into the liver to collect a tissue sample

Study groups in NCT03900429
Study groupRoleWhat they receive
Matching PlaceboPlacebo comparatorPlacebo Daily
Receives: Drug: Placebo; Procedure: Liver Biopsy
80 mg MGL-3196Active comparator80 mg daily
Receives: Drug: MGL-3196; Procedure: Liver Biopsy
100 mg MGL-3196Active comparator100 mg daily
Receives: Drug: MGL-3196; Procedure: Liver Biopsy

What is being measured

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

  1. Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline

    1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR
    2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS

    Measured: 52 weeks

  2. Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months)

    The Composite Clinical Outcome is composed of all-cause mortality, liver transplant, and significant hepatic events (including hepatic decompensation events [ascites, encephalopathy, or gastroesophageal variceal hemorrhage], histological progression to cirrhosis, and a confirmed increase of MELD score from <12 to ≥15).

    Measured: up to 54 months

Secondary outcomes (1)

  1. Week 52 Key Secondary Objective: To determine the effect of once-daily, oral administration of MGL-3196 80 or 100 mg versus matching placebo on the percent change from Baseline at 24 weeks in directly measured low-density lipoprotein cholesterol (LDL-C)

    Assess the effect of MGL-3196 80 mg or 100 mg compared to placebo on LDL-C measured by percent change from Baseline at 24 weeks.

    Measured: 24 weeks

Timeline

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

  1. First posted3 Apr 2019
  2. Study start28 Mar 2019
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900429
Sponsor's protocol ID
MGL-3196-11
Acronym
MAESTRO-NASH
Status last verified
May 2026
First submitted
26 Mar 2019
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schattenberg JM, Bedossa P, Guy CD, Taub R, Labriola D, Zhang H, Hennan J, Camacho RC, Chng E, Ren Y, Tai D, Harrison SA. Quantitative regression of qFibrosis with resmetirom: Exploratory histologic endpoints from the MAESTRO-NASH phase III clinical trial. J Hepatol. 2026 Aug;85(2):202-211. doi: 10.1016/j.jhep.2026.03.021. Epub 2026 Mar 25.

    PubMed 41895606

  • Noureddin M, Rinella M, Taub R, Labriola D, Camacho RC, Alkhouri N, Loomba R, Bansal MB. Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH Trial. Aliment Pharmacol Ther. 2025 Dec;62(11-12):1089-1099. doi: 10.1111/apt.70382. Epub 2025 Oct 23.

    PubMed 41127972

  • Younossi ZM, Stepanova M, Racila A, Henry L, Labriola D, Taub R, Nader F. Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. Hepatology. 2025 Apr 1;81(4):1318-1327. doi: 10.1097/HEP.0000000000001084. Epub 2024 Sep 6.

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  • Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MGL-3196 and Liver Biopsy in people with NASH - Nonalcoholic Steatohepatitis, run by Madrigal Pharmaceuticals, Inc. at 247 sites in 16 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 11 inclusion and 20 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in United States, United Kingdom, France, Australia, Germany and 11 more countries. 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. Some participants in this study may receive a placebo. 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?

Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline (time frame: 52 weeks). The study lists 2 primary outcomes in all. 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 NCT03900429, which also lists 6 linked publications.

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 1 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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