The ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will follow 200 patients with cirrhosis – scarring caused by long-term damage of the liver – to uncover why some patients experience liver failure or develop liver cancer.
Researchers from the Universities of Edinburgh and Newcastle hope their findings will lead to earlier diagnosis and the development of a first-ever approved medicine for cirrhosis.
Urgent need
It is estimated that more than 440 million people worldwide live with a condition referred to as non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) – an inflammatory liver disease that is caused by accumulation of fat in the liver.
Over time, this causes scar tissue to form, which leads in many cases to liver cirrhosis. This can result in serious complications, including liver failure or liver cancer, and may result in the patient needing a liver transplant.
Ongoing assessment
The global study will enroll patients who have been diagnosed with or are thought to be at risk of advanced cirrhosis due to fatty liver disease.
Participants will initially undergo a biopsy to collect a small sample of liver tissue so that detailed changes in how genes are activated in the liver can be assessed.
Blood tests and MRI scans will be performed at regular intervals over the next two years. The data generated will allow researchers to see how disease-related changes evolve in the body as cirrhosis progresses.
The study is funded by pharmaceutical company Boehringer Ingelheim, and researchers will be supported by the University of Edinburgh’s commercialisation service, Edinburgh Innovations.