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)

ID#: NCT04951219

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: July 09, 2021

End Date: December 01, 2022

Contact Information:
Edward Chiang
Summary: 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)

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.