ACTIVE_NOT_RECRUITING

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)

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Conditions

Non-Alcoholic Fatty Liver DiseaseNAFLDNASHHyperlipidemiaResmetiromThyroid hormone receptor betaHepaticFibrosisNASH resolutionThyroid hormone receptor agonistCardiovascularDyslipidemiaFatty liver diseaseNonalcoholic steatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2021-07-09
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04951219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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:
  3. * NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
  4. * NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
  5. * 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
  6. * 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 .
  1. * A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1.
  2. * Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study.
  3. * Chronic liver diseases
  4. * Has an active autoimmune disease
  5. * 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.

Contacts and Locations

Principal Investigator

Rebecca Taub, MD
STUDY_DIRECTOR
Madrigal Pharmaceuticals, Inc.

Study Locations (Sites)

Central Research Associates
Birmingham, Alabama, 35205
United States
Arizona Liver Health - Chandler
Chandler, Arizona, 85224
United States
East Valley Family Physicians
Chandler, Arizona, 85224
United States
The Institute For Liver Health - Glendale
Glendale, Arizona, 85306
United States
The Institute For Liver Health - Tucson
Tucson, Arizona, 85711
United States
Adobe Gastroenterology
Tucson, Arizona, 85712
United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
United States
Fresno Clinical Research Center
Fresno, California, 93720
United States
National Research Institute - Huntington Park
Huntington Park, California, 90255
United States
Ruane Clinical Research Group
Los Angeles, California, 90036
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
National Research Institute - Los Angeles
Los Angeles, California, 90057
United States
National Research Institute - Panorama City
Panorama City, California, 91402
United States
San Fernando Valley Health Institute
West Hills, California, 91307
United States
South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado, 80113
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Covenant Research
Fort Myers, Florida, 33912
United States
Velocity Clinical Research, Hallandale Beach (MD Clinical)
Hallandale Beach, Florida, 33009
United States
Floridian Clinical Research
Hialeah, Florida, 33016
United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, 34452
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Florida Research Institute
Lakewood Ranch, Florida, 34211
United States
Orlando Research Center
Orlando, Florida, 32806
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
Covenant Research
Sarasota, Florida, 34240
United States
The Villages Research Center
The Villages, Florida, 32162
United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814
United States
Chicago Research Center
Chicago, Illinois, 60602
United States
Northwestern Memorial Physicians Group
Chicago, Illinois, 60611
United States
Iowa Diabetes Research
West Des Moines, Iowa, 50265
United States
Kansas Medical Clinic - Gastroenterology
Topeka, Kansas, 66606
United States
L-MARC Research Center
Louisville, Kentucky, 40213
United States
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, 70809
United States
Tandem Clinical Research - New Orleans Area Site
Marrero, Louisiana, 70072
United States
Clinical Trials of America
West Monroe, Louisiana, 71291
United States
Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi, 39232
United States
Southern Therapy and Advanced Research
Jackson, Mississippi, 39216
United States
Kansas City Research Institute
Kansas City, Missouri, 64131
United States
Henderson Research Center
Henderson, Nevada, 89052
United States
Clarity Clinical Research
East Syracuse, New York, 13057
United States
Mount Sinai Health System
New York, New York, 10029
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304
United States
Diabetes and Endocrinology Consultants
Morehead City, North Carolina, 28557
United States
Aventiv Research Columbus
Columbus, Ohio, 43213
United States
Awasty Research Network
Marion, Ohio, 43302
United States
Premier Medical Group - Clarksville - Dunlop Lane
Clarksville, Tennessee, 37040
United States
Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee, 38138
United States
Pinnacle Clinical Research - Austin
Austin, Texas, 78746
United States
The Liver Institute At Methodist Dallas
Dallas, Texas, 75203
United States
Dallas Research Center
Dallas, Texas, 75234
United States
Liver Center of Texas
Dallas, Texas, 75234
United States
South Texas Research Institute
Edinburg, Texas, 78539
United States
Texas Digestive Disease Consultants
Fort Worth, Texas, 76104
United States
Liver Associates of Texas
Houston, Texas, 77030
United States
Doctor's Hospital at Renaissance
McAllen, Texas, 78504
United States
Plano Research Center
Plano, Texas, 75093
United States
Texas Liver Institute/American Research Corporation
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
United States
San Antonio Research Center
San Antonio, Texas, 78229
United States
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666
United States
Impact Research Institute
Waco, Texas, 76710
United States
Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center
Webster, Texas, 77598
United States
Wasatch Peak Family Practice
Layton, Utah, 84041
United States
Salt Lake City Research Center
Murray, Utah, 84123
United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
United States
National Clinical Research - Richmond
Richmond, Virginia, 23294
United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
United States
Liver Institute Northwest
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Madrigal Pharmaceuticals, Inc.

  • Rebecca Taub, MD, STUDY_DIRECTOR, Madrigal Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-09
Study Completion Date2026-04

Study Record Updates

Study Start Date2021-07-09
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • NAFLD
  • NASH
  • Hyperlipidemia
  • Resmetirom
  • Thyroid hormone receptor beta
  • Hepatic
  • Fibrosis
  • NASH resolution
  • Thyroid hormone receptor agonist
  • Cardiovascular
  • Dyslipidemia
  • Fatty liver disease
  • Nonalcoholic steatohepatitis

Additional Relevant MeSH Terms

  • Non-Alcoholic Fatty Liver Disease