A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

To join this study, you would need to have a diagnosis of NASH cirrhosis, meaning you have liver scarring from a non-alcoholic fatty liver condition. Your liver should not be too severely damaged yet, often described as 'well-compensated Child-Pugh A.' You also shouldn't have had any serious liver complications in the past, such as fluid build-up in your tummy or severe confusion due to liver disease.

There are also some reasons why you might not be able to join. For example, if you have other types of liver disease (like Hepatitis B or C), a history of liver cancer, or if your liver function is already very poor. The study also cannot include individuals with a history of alcohol-related liver disease, or if you regularly drink too much alcohol. Certain medications, uncontrolled diabetes, or very low blood platelet counts might also prevent you from participating.

If you decide to take part, you would first go through a screening period of up to 60 days to confirm you meet all the study's requirements. During this time, you'll likely have various tests, including blood tests and liver scans. If you qualify, you'll be randomly assigned to either receive the study drug, resmetirom, or a placebo (dummy pill). You'll take one pill by mouth every morning.

Throughout the study, you'll have regular check-ups, blood tests, and other assessments to monitor your health and how the treatment is affecting you. These visits are important to track any changes in your liver condition and overall well-being. The treatment period is expected to last for about three years, or until a certain number of serious liver-related events have occurred across all participants. You'll be closely monitored by medical staff throughout this time.