Clinical Trial Details

Trial ID: L0009
Source ID: NCT04197479
Associated Drug: Resmetirom
Title: A Phase 3 Study to Evaluate the Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease (NAFLD) Patients
Acronym: MAESTRO-NAFLD1
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-Alcoholic Fatty Liver Disease
Interventions: Drug: Placebo|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.|The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in low density lipoprotein C (LDL-C) from baseline to Week 24|The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in apolipoprotein B (ApoB) from baseline to Week 24|The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in hepatic fat fraction as determined by MRI-PDFF from baseline to Week 16.|The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in triglycerides (TGs) from baseline to Week 24 in patients with baseline TG > 150 mg/dL.|The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo after 52 weeks on N-terminal type III collagen propeptide (PRO-C3) in patients with baseline PRO-C3 ???10 ng/mL.
Sponsor/Collaborators: Madrigal Pharmaceuticals, Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 700
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: December 16, 2019
Completion Date: December 2021
Results First Posted: --
Last Update Posted: July 7, 2020
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|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, Van Nuys, California, United States|South Denver Gastroenterology - Swedish Medical Center Office, Englewood, Colorado, United States|Excel Medical Clinical Trials, Boca Raton, Florida, United States|Medicinae Doctor 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|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|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|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|National Clinical Research - Richmond, Richmond, Virginia, United States|Fundacion de Investigacion de Diego, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT04197479

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D300 Resmetirom Chemical drug DB12914 THRB agonist Anti-fibrosis Advanced in clinical trials Details