MAESTRO-NASH OUTCOMES
Research type
Research Study
Full title
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)
IRAS ID
1006773
Contact name
Rebecca Taub
Sponsor organisation
Madrigal Pharmaceuticals, Inc.
Eudract number
2022-002279-13
Clinicaltrials.gov Identifier
Research summary
Non-alcoholic steatohepatitis (NASH) cirrhosis is a liver disease that is associated with an increased amount of fat and inflammation in the liver. In time, liver cells may be so badly damaged that scar tissue forms within the liver where healthy cells used to be. This is known as NASH cirrhosis and is associated with increased cardiovascular risk, including cardiovascular death. No approved therapy for NASH exists and it is increasing across populations owing to the global prevalence of obesity as well as other components of the metabolic syndrome (e.g., diabetes, high blood pressure). Lifestyle adjustments such as weight loss, exercise and changes to eating habits are effective but difficult to achieve and maintain. Evidence suggests that NASH might be partly due to reduced levels of liver thyroid hormone. The main complication of unmanaged NASH is the progression to NASH cirrhosis (replacement of healthy liver tissue with scar tissue). There are no available treatments for NASH or NASH cirrhosis. NASH alone represents a significant unmet medical need for a large population of patients, and the increased burden on patients who progress to NASH cirrhosis poses a serious health concern. The main purpose of this study is to learn whether an investigational drug, resmetirom, can benefit participants by slowing further disease progression and delaying complications of NASH cirrhosis. 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 fats that are associated with increased risk of heart attacks and strokes. The study will compare resmetirom with placebo, (a substance that looks like the study drug but contains no active medication), to see if resmetirom works better or is safer than taking nothing. The study will last 3 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0123
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion