Clinical Trial Details

Trial ID: L0008
Source ID: NCT04951219
Associated Drug: Resmetirom
Title: 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)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-Alcoholic Fatty Liver Disease
Interventions: Drug: Resmetirom
Outcome Measures: The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.|Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline|Percent change in LDL-C from baseline
Sponsor/Collaborators: Madrigal Pharmaceuticals, Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 1000
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: July 9, 2021
Completion Date: December 2022
Results First Posted: --
Last Update Posted: August 19, 2021
Locations: 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|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|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 Beach, 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 Ranch, 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|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|Platinum - Sterling Research Group - Springdale, Cincinnati, Ohio, 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|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
URL: https://ClinicalTrials.gov/show/NCT04951219