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.
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
Nonalcoholic Fatty Liver Disease (NAFLD)
Elvira Rodriguez, Hirsh Trivedi