Clinical trial NCT03900429: A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Madrigal Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 1759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Must be willing to participate in the study and provide written informed consent.
2. Male and female adults ≥ 18 years of age.
3. 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:

   1. Historical biochemical test for fibrosis: PRO-C3 \>14 ng/mL or ELF ≥9
   2. FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
   3. 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.
4. MRI-PDFF fat fraction ≥8% obtained during the screening period
5. 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:

   1. Steatosis (scored 0 to 3)
   2. Ballooning degeneration (scored 0 to 2)
   3. Lobular inflammation (scored 0 to 3)

Exclusion Criteria:

1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
2. Regular use of drugs historically associated with NAFLD
3. Thyroid diseases:

   1. Active hyperthyroidism.
   2. Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) \>7 IU/L with symptoms of hypothyroidism or \>10 IU/L without symptoms.
   3. Patients who have had a thyroidectomy and are on replacement thyroxine doses \>75 µg per day are allowed.
4. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
5. Recent significant weight gain or loss
6. HbA1c ≥ 9.0%.
7. 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.
8. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
9. Diagnosis of hepatocellular carcinoma (HCC).
10. MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
11. Hepatic decompensation
12. Chronic liver diseases other than NASH
13. Active autoimmune disease
14. Serum ALT \> 250 U/L.
15. Active, serious medical disease with a likely life expectancy \< 2 years.
16. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
17. 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.

Primary outcomes:
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
timeFrame: 52 weeks
measure: Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months)
timeFrame: up to 54 months
Secondary outcomes:
measure: 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)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians
state: Arizona
city: Chandler
country: United States
facility: The Institute for Liver Health - Chandler
state: Arizona
city: Glendale
country: United States
facility: The Institute for Liver Health - Glendale
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Adobe Gastroenterology
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health - Tucson
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Los Angeles
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Panorama City
country: United States
facility: National Research Institute - Panorama City
state: California
city: Poway
country: United States
facility: Alliance Clinical Research
state: California
city: Van Nuys
country: United States
facility: San Fernando Valley Health Institute
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Family Practice
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology - Swedish Medical Center Office
state: Colorado
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists - Fort Myers
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research - Orlando
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Covenant Research
state: Florida
city: The Villages
country: United States
facility: Bioclinica Research - The Villages
state: Florida
city: Marietta
country: United States
facility: GI Specialists of Georgia
state: Georgia
city: Chicago
country: United States
facility: Clinical Research - Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Fairway
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic - Gastroenterology
state: Kansas
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America
state: Louisiana
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Flowood
country: United States
facility: Gastrointestinal Associates and Endoscopy Center - Madison
state: Mississippi
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Henderson
country: United States
facility: Clinical Research US - Henderson
state: Nevada
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: University of North Carolina Medical Center - Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research - Columbus
state: Ohio
city: Marion
country: United States
facility: Awasty Research Network
state: Ohio
city: Clarksville
country: United States
facility: Premier Medical Group - Clarksville
state: Tennessee
city: Germantown
country: United States
facility: Gastro One - Germantown - Centre Oak Way
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Knoxville
country: United States
facility: Gastrointestinal Associates - Knoxville
state: Tennessee
city: Brownsville
country: United States
facility: South Texas Research Institute - Brownsville
state: Texas
city: Dallas
country: United States
facility: Dallas Research Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultants - Fort Worth
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: McAllen
country: United States
facility: Doctor's Hospital at Renaissance
state: Texas
city: Plano
country: United States
facility: Plano Research Center
state: Texas
city: Rollingwood
country: United States
facility: Pinnacle Clinical Research - Austin
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Research Center
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants - San Marcos
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Webster
country: United States
facility: Texas Digestive Disease Consultants - Bay Area Gastroenterology
state: Texas
city: Layton
country: United States
facility: Wasatch Peak Family Practice
state: Utah
city: Murray
country: United States
facility: Salt Lake City Research Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Administration Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: Saint Vincent's Hospital Sydney
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt Am Wörthersee
state: Carinthia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
state: Upper Austria
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung
state: Vienna
city: Salzburg
country: Austria
facility: Landesklinik St. Veit
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
state: Brussels
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
state: Flemish Brabant
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg'
state: Limburg
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta Campus Wilgenstraat
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Laeken
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Calgary
country: Canada
facility: University of Calgary Liver Unit
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Bridgewater
country: Canada
facility: South Shore Medical Arts
state: Nova Scotia
city: Brampton
country: Canada
facility: LMC/ Manna Research - Brampton
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital - Clinical Trials Pharmacy
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Center
state: Ontario
city: Vancouver
country: Canada
facility: Lair Centre
city: Vancouver
country: Canada
facility: GI Research Institute
city: Strasbourg Cedex
country: France
facility: Nouvel Hôpital Civil
state: Alsace
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre
state: Alsace
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing
state: Auvergne
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes
state: Bretagne
city: Besançon
country: France
facility: Hôpital Jean-Minjoz
state: Franche-Comte
city: Bobigny Cedex
country: France
facility: Hôpital Avicenne
state: Ile-de-France
city: Créteil Cedex
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
state: Ile-de-France
city: Paris Cedex 14
country: France
facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin
state: Ile-de-France
city: Montpellier Cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier
state: Languedoc-Roussillon
city: Limoges
country: France
facility: Hôpital Dupuytren
state: Limousin
city: Toulouse Cedex
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
state: Midi-Pyrenees
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
state: Nord Pas-de-Calais
city: Angers
country: France
facility: Center Hospitalier Universitaire d'Angers
state: Pays De La Loire
city: Nice Cedex 3
country: France
facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet
state: Provence Alpes Cote D'Azur
city: Lyon Cedex 04
country: France
facility: Hôpital de la Croix Rousse
state: Rhone-Alpes
city: Amiens
country: France
facility: Centre Hospitalier Universitaire Amiens-Picardie
city: Clichy
country: France
facility: Hôpital Beaujon
city: Paris Cedex 13
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
city: Berlin
country: Germany
facility: Berlin Clinical Research Center
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Mitte
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: EPIMED
city: Berlin
country: Germany
facility: Zentrum für Infektiologie Berlin Prenzlauer Berg
city: Frankfurt am main
country: Germany
facility: Frankfurt Clinical Research Center
city: Frankfurt am main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: EUGASTRO
city: Leipzig
country: Germany
facility: Leipzig Research Center
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
state: Bekes
city: Gyula
country: Hungary
facility: Magyarország Egészségügyi Szolgáltató - Gyula
state: Bekes
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház
state: Hajdu-Bihar
city: Debrecen
country: Hungary
facility: Magyarország Research Center
state: Hajdu-Bihar
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
city: Budapest
country: Hungary
facility: Magyarország Research Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
state: Tel Aviv
city: Afula
country: Israel
facility: Emek Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus - Rambam Medical Center
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital-Nahariya
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Firenze
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Ciudad de México
country: Mexico
facility: Centro Mexicano de Desarrollo de Estudios Clínicos
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Centro de Investigacion y Gastroenterologia
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatología
state: Jalisco
city: Cuernavaca
country: Mexico
facility: JM Research
state: Morelos
city: Monterrey
country: Mexico
facility: Investigaciones Médicas Cisneros
state: Nuevo Leon
city: Częstochowa
country: Poland
facility: Polska Oddział w Częstochowie
city: Gdańsk
country: Poland
facility: Polska Oddział w Gdansk
city: Gdynia
country: Poland
facility: Polska Oddział w Gdyni
city: Katowice
country: Poland
facility: Polska Oddział w Katowicach
city: Poznań
country: Poland
facility: Polska Oddział w Poznaniu
city: Skórzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: Polska Oddział w Warszawie
city: Wrocław
country: Poland
facility: Polska Oddział w Wrocław
city: Łódź
country: Poland
facility: Polska Oddział w Łodz
city: San Juan
country: Puerto Rico
facility: Fundación De Investigación De Diego
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de València
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Bern
country: Switzerland
facility: Universitatsspital Bern
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
city: Zürich
country: Switzerland
facility: Universitatsspital Zurich
city: Birmingham
country: United Kingdom
facility: Midlands Clinical Research Centre
state: England
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: England
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: England
city: Chorley
country: United Kingdom
facility: Lancashire Clinical Research Centre
state: England
city: Hardwick
country: United Kingdom
facility: North Teesside Clinical Research Centre
state: England
city: Liverpool
country: United Kingdom
facility: Merseyside Clinical Research Centre
state: England
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: England
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: England
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
state: England
city: Manchester
country: United Kingdom
facility: Manchester Clinical Research Centre
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: England
city: Reading
country: United Kingdom
facility: Thames Valley Dedicated Research Centre
state: England
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Northern Ireland
city: Hexham
country: United Kingdom
facility: The Hexham Clinic
state: Northumberland, England
city: Cardiff
country: United Kingdom
facility: The Wales Clinic
state: Wales
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Health Board
state: Wales
city: Liverpool
country: United Kingdom
facility: Aintree University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Saint George's University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
affiliation: Madrigal Pharmaceuticals, Inc.
name: Rebecca Taub, MD
role: STUDY_DIRECTOR
References:
citation: Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.