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)
- Registration Number
- NCT04951219
- Lead Sponsor
- Madrigal Pharmaceuticals, Inc.
- Brief Summary
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent.
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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
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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 .
- A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open-label Resmetirom 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). Open Label 100 mg Resmetirom For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks Double-blind 100 mg Daily Resmetirom 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 Open-Label 40 mg Resmetirom 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 Open-Label 80 mg Resmetirom For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for 104 weeks Double-blind 80 mg Daily Resmetirom 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
- Primary Outcome Measures
Name Time Method The effect of once daily, oral administration of resmetirom on the incidence of adverse events. 52 weeks
- Secondary Outcome Measures
Name Time Method Percent change in LDL-C from baseline 28 weeks Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline 52 weeks
Related Research Topics
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Trial Locations
- Locations (73)
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Platinum - Sterling Research Group - Springdale
🇺🇸Cincinnati, Ohio, United States
Texas Liver Institute/American Research Corporation
🇺🇸San Antonio, Texas, United States
San Antonio Research Center
🇺🇸San Antonio, Texas, United States
Iowa Diabetes Research
🇺🇸West Des Moines, Iowa, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Dallas Research Center
🇺🇸Dallas, Texas, United States
Covenant Research
🇺🇸Sarasota, Florida, United States
The Institute For Liver Health - Glendale
🇺🇸Glendale, Arizona, United States
Arizona Liver Health - Chandler
🇺🇸Chandler, Arizona, United States
The Institute For Liver Health - Tucson
🇺🇸Tucson, Arizona, United States
Floridian Clinical Research
🇺🇸Hialeah, Florida, United States
Nature Coast Clinical Research - Inverness
🇺🇸Inverness, Florida, United States
Premier Medical Group - Clarksville - Dunlop Lane
🇺🇸Clarksville, Tennessee, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Digestive Health Center of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
Tandem Clinical Research - New Orleans Area Site
🇺🇸Marrero, Louisiana, United States
Gastrointestinal Associates & Endoscopy Center - Flowood
🇺🇸Flowood, Mississippi, United States
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Fresno Clinical Research Center
🇺🇸Fresno, California, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, 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
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
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Chicago Research Center
🇺🇸Chicago, Illinois, United States
Kansas Medical Clinic - Gastroenterology
🇺🇸Topeka, Kansas, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Northwestern Memorial Physicians Group
🇺🇸Chicago, Illinois, United States
Mount Sinai Health System
🇺🇸New York, New York, United States
Clarity Clinical Research
🇺🇸East Syracuse, New York, United States
Southern Therapy and Advanced Research
🇺🇸Jackson, Mississippi, United States
Henderson Research Center
🇺🇸Henderson, Nevada, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Diabetes and Endocrinology Consultants
🇺🇸Morehead City, North Carolina, United States
Awasty Research Network
🇺🇸Marion, Ohio, United States
Aventiv Research Columbus
🇺🇸Columbus, Ohio, United States
Gastro One - Germantown Office - Wolf Park Drive
🇺🇸Germantown, Tennessee, United States
The Liver Institute At Methodist Dallas
🇺🇸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
Plano Research Center
🇺🇸Plano, Texas, United States
Pinnacle Clinical Research - San Antonio
🇺🇸San Antonio, Texas, United States
Texas Digestive Disease Consultants - San Marcos
🇺🇸San Marcos, Texas, United States
Impact Research Institute
🇺🇸Waco, Texas, United States
Wasatch Peak Family Practice
🇺🇸Layton, Utah, United States
Salt Lake City Research Center
🇺🇸Murray, Utah, United States
Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center
🇺🇸Webster, Texas, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Catalina Research Institute
🇺🇸Montclair, California, United States
East Valley Family Physicians
🇺🇸Chandler, Arizona, United States
Adobe Gastroenterology
🇺🇸Tucson, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, Hallandale Beach (MD Clinical)
🇺🇸Hallandale Beach, Florida, United States
The Villages Research Center
🇺🇸The Villages, Florida, United States
Clinical Trials of America
🇺🇸West Monroe, Louisiana, United States
Doctor's Hospital at Renaissance
🇺🇸McAllen, Texas, United States
Pinnacle Clinical Research - Austin
🇺🇸Austin, Texas, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Orlando Research Center
🇺🇸Orlando, Florida, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, 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