A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)
NCT ID: NCT04951219
Last Updated: 2025-08-03
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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ACTIVE_NOT_RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2021-07-09
2026-04-30
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
TRIPLE
Study Groups
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Double-blind 80 mg Daily
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Resmetirom
Tablet
Double-blind 100 mg Daily
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Resmetirom
Tablet
Open-label
For patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for an additional 52 weeks (ie, 52 weeks in MGL-3196-14 and 104 weeks in MGL-3196-18).
Resmetirom
Tablet
Open-Label 80 mg
For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for 104 weeks
Resmetirom
Tablet
Open Label 100 mg
For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
Resmetirom
Tablet
Open-Label 40 mg
For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for 104 weeks
Resmetirom
Tablet
Interventions
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Resmetirom
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results:
* NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
* NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
* Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD \<12, albumin ≥3.2, and bilirubin \<2
* For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score \<8) NASH cirrhosis (including minimal decompensation) and MELD \<15 unless MELD \>=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE .
Exclusion Criteria
* Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study.
* Chronic liver diseases
* Has an active autoimmune disease
* Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
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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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
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
Cedars-Sinai Medical Center
Los Angeles, California, United States
National Research Institute - Los Angeles
Los Angeles, California, United States
National Research Institute - Panorama City
Panorama City, 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
Covenant Research
Fort Myers, 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
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
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
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
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
Aventiv Research Columbus
Columbus, Ohio, United States
Awasty Research Network
Marion, Ohio, 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
South Texas Research Institute
Edinburg, Texas, United States
Texas Digestive Disease Consultants
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
Impact Research Institute
Waco, 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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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-3196-18
Identifier Type: -
Identifier Source: org_study_id
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