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)

Inclusion Criteria:

• For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completedthe Week 56 visit within 90 days of the Extension Day 1 visit, and are willing toparticipate in MAESTRO-NAFLD-OLE and provide written informed consent.
• For patients who screen failed MAESTRO-NASH, must provide written informed consent forMAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements forMAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE andhave a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of theExtension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one ofthe following results:
• NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0,with F1B, F2 or F3
• NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, butineligible for MAESTRO-NASH)
• Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH andbaseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD <12,albumin ≥3.2, and bilirubin <2
• For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, musthave documented CP-A/B (score <8) NASH cirrhosis (including minimal decompensation)and MELD <15 unless MELD >=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMESscreen failures must have screened and met all eligibility requirements forMAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit forMAESTRO-NAFLD-OLE .

Exclusion Criteria:

• A history of significant alcohol consumption for a period of more than 3 consecutivemonths within 1 year prior to Extension Day 1.
• Diagnosis of hepatocellular carcinoma or other carcinomas that may preventparticipation in the Extension study.
• Chronic liver diseases
• Has an active autoimmune disease
• Any other condition which, in the opinion of the Investigator, would impedecompliance, hinder completion of the study, compromise the well-being of the patient,or interfere with the study outcomes.