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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)
Sponsor: Madrigal Pharmaceuticals, Inc.
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)
Official title: A 52-Week, Phase 3, Open-Label Extension Study, With a Double-blind Lead-in, 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2021-07-09
Completion Date
2026-04
Last Updated
2025-08-03
Healthy Volunteers
No
Conditions
Interventions
Resmetirom
Tablet
Locations (71)
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