A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
NCT ID: NCT04197479
Last Updated: 2023-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1343 participants
INTERVENTIONAL
2019-12-16
2023-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Open label: resmetirom
100 mg daily
Resmetirom
Tablet
Double blinded: matching placebo
Placebo daily
Placebo
Matching tablets
Double blinded: resmetirom 80 mg
80 mg daily
Resmetirom
Tablet
Double blinded: resmetirom 100 mg
100 mg daily
Resmetirom
Tablet
Interventions
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Placebo
Matching tablets
Resmetirom
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female adults ≥18 years of age.
* Suspected or confirmed diagnosis of NASH or NAFLD (presumed NASH):
* Fibroscan with kPa ≥5.5 and \<8.5; CAP ≥280 dB.m-1 OR
* MRE ≥2 and \<4.0; MRI-PDFF ≥8% liver fat consistent with steatosis and fibrosis stage ≥1 and \<4. OR
* Recent liver biopsy (within past 2 years) documenting NASH/NAFLD with steatosis showing one of the following:
* NAS ≥4, steatosis ≥1, fibrosis stage 0 or F1A/1C with PRO-C3 \<14
* NAS \<4, steatosis ≥1, with fibrosis stage ≤3
* NAS ≥4, steatosis ≥1, fibrosis stage ≤3 without ballooning
* NOTE: Since the completion of enrollment of the double-blind arms, patients meeting all other criteria who have a liver biopsy result from MGL-3196-11 with the following may be enrolled in the open-label active treatment arm of MGL-3196-14 (100 mg dose):
* NAS = 3, steatosis 1, ballooning 1, inflammation 1 with F2 or F3
* NAS = 3, ballooning 0 with F2 or F3
* For the compensated NASH cirrhosis arm, eligible patients must have compensated NASH cirrhosis diagnosed by liver biopsy showing NASH with F4 stage fibrosis (either historic or recent biopsy) or a historic biopsy with NASH F2-F3 fibrosis with subsequent progression to NASH cirrhosis as diagnosed by an expert hepatologist/gastroenterologist.
* Compensated NASH cirrhosis at screening and baseline includes
* Child Pugh-A (score 5-6) ( may have either mild hepatic encephalopathy OR mild diuretic responsive ascites OR albumin \< 3.5 and ≥ 3.2 (not any two of these, unless explained by Gilbert's Syndrome or non-hepatic causes)).
* MELD \< 12 at screening/baseline unless MELD ≥ 12 based on non-cirrhotic parameters (e.g., elevated INR due to anticoagulation, bilirubin elevation due to documented Gilbert's Syndrome, elevated creatine due to renal disease (non-hepatic)).
* Albumin ≥ 3.2.
* Bilirubin \< 2 (unless documented Gilbert's Syndrome).
* MRI-PDFF fat fraction ≥8% obtained during the Screening Period (baseline MRI-PDFF) or a historic MRI-PDFF ≤8 weeks old at the time of randomization.
* Stable dyslipidemia therapy for ≥30 days prior to randomization.
Exclusion Criteria
* Regular use of drugs historically associated with NAFLD.
* History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
* Weight gain or loss ≥5% total body weight within 12 weeks prior to randomization.
* HbA1c \>9.0%.
* Glucagon-like peptide 1 \[GLP-1\] agonist therapy or high dose vitamin E (\>400 IU/day) unless stable for 24 weeks prior to biopsy.
* Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
* Diagnosis of hepatocellular carcinoma (HCC).
* Model for End-stage Liver Disease (MELD) score ≥12, as determined at Screening, unless due to therapeutic anti coagulation or Gilbert syndrome.
* Hepatic decompensation.
* Chronic liver diseases.
* Has an active autoimmune disease.
* Serum ALT \>250 U/L.
* History of biliary diversion.
* Uncontrolled hypertension (either treated or untreated).
* 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, prior to randomization.
* 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.
18 Years
ALL
No
Sponsors
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Madrigal Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Taub, MD
Role: STUDY_DIRECTOR
Madrigal Pharmaceuticals, Inc.
Locations
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East-West Medical Research Institute
Honolulu, Hawaii, United States
Chicago Research Center
Chicago, Illinois, United States
Northwestern Memorial Physicians Group
Chicago, Illinois, United States
Iowa Diabetes Research
West Des Moines, Iowa, United States
Central Research Associates
Birmingham, Alabama, United States
Arizona Liver Health - Chandler
Chandler, Arizona, United States
East Valley Family Physicians
Chandler, Arizona, United States
The Institute For Liver Health - Glendale
Glendale, Arizona, United States
Arizona - Desert Clinical Research
Mesa, Arizona, United States
The Institute For Liver Health - Tucson
Tucson, Arizona, United States
Adobe Gastroenterology
Tucson, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Fresno Clinical Research Center
Fresno, California, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
Ruane Clinical Research Group
Los Angeles, California, United States
National Research Institute - Los Angeles
Los Angeles, California, United States
Catalina Research Institute
Montclair, California, United States
National Research Institute - Panorama City
Panorama City, California, United States
Alliance Clinical Research
Poway, California, United States
San Fernando Valley Health Institute
West Hills, California, United States
South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Velocity Clinical Research, Hallandale Beach (MD Clinical)
Hallandale, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Miami Dade Medical Research Institute
Miami, Florida, United States
Orlando Research Center
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Research
Sarasota, Florida, United States
The Villages Research Center
The Villages, Florida, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Kansas Medical Clinic - Gastroenterology
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, United States
Tandem Clinical Research - New Orleans Area Site
Marrero, Louisiana, United States
Clinical Trials of America
West Monroe, Louisiana, United States
Huron Gastroenterology
Ypsilanti, Michigan, United States
Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi, United States
Southern Therapy and Advanced Research
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Henderson Research Center
Henderson, Nevada, United States
Clarity Clinical Research
East Syracuse, New York, United States
Mount Sinai Health System
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
Diabetes and Endocrinology Consultants
Morehead City, North Carolina, United States
TMA - Wilmington Gastroenterology Accociates
Wilmington, North Carolina, United States
Platinum - Sterling Research Group - Springdale
Cincinnati, Ohio, United States
Aventiv Research Columbus
Columbus, Ohio, United States
Awasty Research Network
Marion, Ohio, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Premier Medical Group - Clarksville - Dunlop Lane
Clarksville, Tennessee, United States
Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
The Liver Institute At Methodist Dallas
Dallas, Texas, United States
Dallas Research Center
Dallas, Texas, United States
Liver Center of Texas
Dallas, Texas, United States
Texas Digestive Disease Consultants - Dallas - Baylor University Medical Center Gaston Ave
Dallas, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
Texas Digestive Disease Consultants - Forth Worth - Downtown
Fort Worth, Texas, United States
Liver Associates of Texas
Houston, Texas, United States
Doctor's Hospital at Renaissance
McAllen, Texas, United States
Plano Research Center
Plano, Texas, United States
Texas Liver Institute/American Research Corporation
San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States
San Antonio Research Center
San Antonio, Texas, United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, United States
Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center
Webster, Texas, United States
Wasatch Peak Family Practice
Layton, Utah, United States
Salt Lake City Research Center
Murray, Utah, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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References
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Alkhouri N, McRae MP, Taub R, Hill B, Imperial JC, Kittelson J, Moussa SE, Everson GT. The Cholate Challenge Test Quantified Baseline Functional Heterogeneity and Improvement in Response to Resmetirom in MASH-related Child-Pugh A Cirrhosis. Gastro Hep Adv. 2025 Aug 29;4(10):100785. doi: 10.1016/j.gastha.2025.100785. eCollection 2025.
Harrison SA, Taub R, Neff GW, Lucas KJ, Labriola D, Moussa SE, Alkhouri N, Bashir MR. Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2023 Nov;29(11):2919-2928. doi: 10.1038/s41591-023-02603-1. Epub 2023 Oct 16.
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.
Other Identifiers
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MGL-3196-14
Identifier Type: -
Identifier Source: org_study_id
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