A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)
Principal Investigator
Sponsor
Madrigal Pharmaceuticals, Inc. has begun a study of an investigational product (also known as the “study drug”) called resmetirom as a possible treatment for NASH cirrhosis. An investigational drug is one that has not been approved by regulatory agencies, such as the US FDA, European Union (EU) European Medicines Agency (EMA), or 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 scarring that are associated with NASH cirrhosis. Resmetirom also reduces cholesterol, triglycerides, and other lipids that are associated with increased risk of heart attacks and strokes. The main purpose of this study is to learn whether treatment with resmetirom compared with placebo for several years can benefit participants by slowing further disease progression and delaying complications of NASH cirrhosis. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing. From here on, resmetirom and placebo will be referred to as the “study drug”.
This study is currently enrolling.