What is the Purpose of this Study?
The purpose of this study is to determine the safety and effectiveness of an investigational drug called resmetirom in people with NASH/NAFLD and compensated cirrhosis. Specifically, the study will examine how well resmetirom works for the reduction of LDL-cholesterol, triglycerides, and other elevated lipids, as well as for reduction in liver fat. Researchers also want to learn the effectiveness of resmetirom in reducing blood and imaging markers of NASH/NAFLD. Study procedures include blood draws, electrocardiograms, and imaging, among others. Resmetirom works together with a type of thyroid hormone receptor in the liver to decrease the amount of fat that has built up in the liver and possibly reduce the inflammation and fibrosis that are associated with NASH.
Eligibility
- * 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.
- * 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:
- * NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A 52-Week, Phase 3 Open-Label Extension Study, with a Double-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom in Patients with Non-alcoholic Fatty Liver Disease , MAESTRO-NAFLD-Open-Label-Extension