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)
Non-Alcoholic Fatty Liver Disease
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, NASH, Hyperlipidemia, Resmetirom, Thyroid hormone receptor beta, Hepatic, Fibrosis, NASH resolution, Thyroid hormone receptor agonist, Cardiovascular, Dyslipidemia, Fatty liver disease, Nonalcoholic steatohepatitis
Eligibility Criteria
Inclusion Criteria:
- Must have participated in 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 the Extension study and provide written informed consent.
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 with F2 or F3
- NAS = 3, ballooning 0 with F2 or F3
- NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
Exclusion Criteria:
- 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.
Sites / Locations
- Central Research AssociatesRecruiting
- Arizona Liver Health - ChandlerRecruiting
- East Valley Family PhysiciansRecruiting
- The Institute For Liver Health - GlendaleRecruiting
- The Institute For Liver Health - TucsonRecruiting
- Adobe GastroenterologyRecruiting
- Arkansas GastroenterologyRecruiting
- Fresno Clinical Research CenterRecruiting
- National Research Institute - Huntington ParkRecruiting
- Ruane Clinical Research GroupRecruiting
- National Research Institute - Los AngelesRecruiting
- Catalina Research InstituteRecruiting
- National Research Institute - Panorama CityRecruiting
- San Fernando Valley Health InstituteRecruiting
- South Denver Gastroenterology - Swedish Medical Center OfficeRecruiting
- Excel Medical Clinical TrialsRecruiting
- Velocity Clinical Research, Hallandale Beach (MD Clinical)Recruiting
- Floridian Clinical ResearchRecruiting
- Nature Coast Clinical Research - InvernessRecruiting
- Jacksonville Center for Clinical ResearchRecruiting
- Florida Research InstituteRecruiting
- Miami Dade Medical Research InstituteRecruiting
- Orlando Research CenterRecruiting
- Progressive Medical ResearchRecruiting
- Covenant ResearchRecruiting
- The Villages Research CenterRecruiting
- Gastrointestinal Specialists of GeorgiaRecruiting
- East-West Medical Research InstituteRecruiting
- Chicago Research CenterRecruiting
- Northwestern Memorial Physicians GroupRecruiting
- Iowa Diabetes ResearchRecruiting
- Kansas Medical Clinic - GastroenterologyRecruiting
- L-MARC Research CenterRecruiting
- Digestive Health Center of LouisianaRecruiting
- Tandem Clinical Research - New Orleans Area SiteRecruiting
- Clinical Trials of AmericaRecruiting
- Gastrointestinal Associates & Endoscopy Center - FlowoodRecruiting
- Southern Therapy and Advanced ResearchRecruiting
- Kansas City Research InstituteRecruiting
- Henderson Research CenterRecruiting
- Clarity Clinical ResearchRecruiting
- Mount Sinai Health SystemRecruiting
- Duke University Medical CenterRecruiting
- Cumberland Research AssociatesRecruiting
- Diabetes and Endocrinology ConsultantsRecruiting
- Platinum - Sterling Research Group - SpringdaleRecruiting
- Aventiv Research ColumbusRecruiting
- Awasty Research NetworkRecruiting
- Premier Medical Group - Clarksville - Dunlop LaneRecruiting
- Gastro One - Germantown Office - Wolf Park DriveRecruiting
- Pinnacle Clinical Research - AustinRecruiting
- The Liver Institute At Methodist DallasRecruiting
- Dallas Research CenterRecruiting
- Liver Center of TexasRecruiting
- South Texas Research InstituteRecruiting
- Liver Associates of TexasRecruiting
- Doctor's Hospital at RenaissanceRecruiting
- Plano Research CenterRecruiting
- Texas Liver Institute/American Research CorporationRecruiting
- Pinnacle Clinical Research - San AntonioRecruiting
- San Antonio Research CenterRecruiting
- Texas Digestive Disease Consultants - San MarcosRecruiting
- Texas Digestive Disease Consultants - Bay Area Houston Endoscopy CenterRecruiting
- Wasatch Peak Family PracticeRecruiting
- Salt Lake City Research CenterRecruiting
- Bon Secours Liver Institute of RichmondRecruiting
- National Clinical Research - RichmondRecruiting
- Virginia Commonwealth University School of MedicineRecruiting
- Liver Institute NorthwestRecruiting
- Fundacion de Investigacion de DiegoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Single-blind 80 mg Daily
Single-blind 100 mg Daily
Open-label 100 mg Daily
Single-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Single-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Open-label resmetirom 100 mg for an additional 52 weeks