A new project led by the University of Edinburgh will investigate the causes of non-alcoholic fatty liver disease, aiming to ‘pave the way’ for new treatments for people living with cirrhosis.

The University of Edinburgh has today announced a collaboration with Newcastle University and research-driven biopharmaceutical company, Boehringer Ingelheim, on the ‘most extensive’ clinical study into liver cirrhosis ever conducted.

Researchers involved in the ADVANCE study will look to enhance the understanding of non-alcoholic cirrhosis, which marks the advanced stages of liver disease.

The team say their findings could help to find biomarkers that will accelerate the development of future therapies.

Professor Neil Henderson, Professor of Tissue Repair and Regeneration at the University of Edinburgh and co-lead on the study, says the study builds on research advances made in Edinburgh and Newcastle:

“Liver disease has reached epidemic proportions worldwide. Therefore, there is a huge need to develop potent, new treatments for liver scarring.

“To help address this, over the last several years we have harnessed a new technology in Edinburgh called single cell RNA sequencing.

“Using this new technology has allowed us to study human liver scarring in high definition for the first time, and we hope that this state-of-the-art approach will allow us to accelerate the discovery of much-needed new treatments for patients with liver disease.”

The study will include 200 patients who have been diagnosed with or are thought to be at risk of advanced liver tissue scarring or cirrhosis due to fatty liver disease.

Professor Henderson and his team will be supported by the University of Edinburgh’s commercialisation service, Edinburgh Innovations, Edinburgh Royal Infirmary and experts across Europe.

Around 444 million people globally live with a condition called non-alcoholic steatohepatitis or metabolic dysfunction-associated steatohepatitis (NASH/MASH).

Accumulation of fat in the liver associated with this condition can cause complete liver failure or even liver cancer resulting in patients needing a transplant, but there are currently no approved medicines for cirrhosis.

Enrolling the largest number of patients for a study of its kind, this project will provide a detailed analysis of liver health – with researchers saying they hope to help address the ‘urgent need’ for earlier diagnosis and new medicines.

With £30m funding from Boehringer, the Edinburgh and Newcastle teams will collaborate to better understand the “substantial variation” in how the disease progresses.

Lykke Hinsch Gylvin, M.D., Chief Medical Officer at Boehringer Ingelheim, says the ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will take a whole-patient approach:

“Cardiovascular, renal, and metabolic (CRM) diseases are the leading cause of death worldwide, accounting for up to 20 million deaths annually.

“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.”

Participants will be recruited either via referral from their doctor or at specialist liver clinics and will initially undergo a biopsy to collect a small sample of liver tissue.

This will help researchers take a detailed look at the changes in gene expression in the liver using advanced scientific techniques.

After examining the biopsies, researchers will take blood tests and ‘state-of-the-art MRI scans’ at regular intervals over the next two years.

Researchers will then be able to explore how disease-related changes evolve in the body as cirrhosis progresses.

Professor of Experimental Hepatology at Newcastle University and Consultant Hepatologist at Newcastle Hospitals NHS Foundation Trust, Professor Quentin Anstee, says this study will “reveal the fundamental disease processes” driving cirrhosis:

“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.”

The research team says anyone interested in participating should discuss it with their doctor.

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