The most extensive clinical study into liver cirrhosis ever conducted worldwide has been announced by Newcastle University, University of Edinburgh and major research-driven global biopharmaceutical company, Boehringer Ingelheim.
The ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will be the most detailed observational study of its kind, enrolling the largest number of patients and providing a detailed analysis of liver health.
The study aims to enhance the understanding of NASH cirrhosis and help to identify translational biomarkers that will accelerate the development of future therapies.
Study co-ordinator Professor Quentin Anstee is Professor of Experimental Hepatology at Newcastle University and Consultant Hepatologist at Newcastle Hospitals NHS Foundation Trust.
The researcher said: “We aim to work out why, even at the most advanced stages of liver disease, there is substantial variation in how the disease progresses with some people remaining well for many years whilst others rapidly experience liver failure or develop liver cancer.
“Working internationally with our collaborators, we will then use this knowledge to improve how patients are diagnosed, and to help develop new medicines.”
Around 444 million people worldwide are estimated to live with a condition referred to as nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) – an inflammatory liver disease that is caused by accumulation of fat in the liver.
Over time, NASH causes scar tissue to form, leading in many cases to liver cirrhosis.
This can result in serious complications, including liver failure or liver cancer and may result in the patient requiring a liver transplant.
There are currently no approved medicines for cirrhosis and so there is an urgent need for earlier diagnosis and new medicines to prevent MASH cirrhosis progression to liver failure, or to reverse the scarring of the liver once cirrhosis is established.
The study will include 200 patients with cirrhosis who will be recruited at specialist liver clinics at hospitals across the UK and Europe or through referral by their treating physician.
This study will enrol patients who have been diagnosed with or are thought to be at risk of advanced fibrosis or cirrhosis due to fatty liver disease (Metabolic-dysfunction Associated Steatotic Liver Disease (MASLD), formerly termed Non-Alcoholic Fatty Liver Disease (NAFLD)).
Participants will first undergo a biopsy to collect a small sample of liver tissue so that detailed changes in gene expression in the liver can be assessed using advanced scientific techniques.
They will then undergo blood tests and state-of-the-art MRI scans performed at regular time points over the next two years.
The data generated will be combined to enableresearchers to see how disease-related changes evolve in the body as cirrhosis progresses.
This £30 million study is funded by Boehringer Ingelheim and reflects the company’s commitment to improve the lives of people living with cardiovascular, renal and metabolic diseases (CRM), the company said in a press release.
Lykke Hinsch Gylvin, M.D., Chief Medical Officer at Boehringer Ingelhei, said: “At Boehringer Ingelheim we are focusing on understanding the whole patient and how to target specific disease mechanisms to address interconnected CRM diseases.
“We are very excited to work with our partners in the ADVANCE study to better understand the underlying disease processes and to bring much needed new treatments to patients with liver cirrhosis.”