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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03900429
Other study ID # MGL-3196-11
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 28, 2019
Est. completion date January 2028

Study information

Verified date February 2024
Source Madrigal Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1759
Est. completion date January 2028
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
MGL-3196
Tablet
Placebo
Matching Tablets
Procedure:
Liver Biopsy
A procedure in which a needle is inserted into the liver to collect a tissue sample

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Madrigal Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Poland,  Puerto Rico,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
52 weeks
Primary 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). up to 54 months
Secondary 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. 24 weeks
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