European researchers will conduct the largest trial ever in liver disease

Cirrhosis and liver cancer pose a significant burden on healthcare systems, impacting quality of life, work productivity, and necessitating specialized medical care. The key risk factors for both cirrhosis and cancer include obesity, type 2 diabetes, and increased alcohol consumption—trends that are on the rise across Europe and globally. Unfortunately, these diseases often progress silently until severe symptoms and complications arise. While liver transplantation is an effective treatment, it is not universally accessible.

Professor Aleksander Krag from the Center for Liver Research at OUH says,
"Mortality and morbidity from advanced liver disease are comparable to what we know from aggressive forms of cancer. More than half die within two years, and not everyone can receive a new liver. Early detection and diagnosis provide an opportunity to change the factors driving these diseases."

However, if liver disease is detected early, during the fibrosis stage, severe outcomes can be reversed and prevented. Enter the LIVERAIM project: a collaboration of renowned clinical centres and industrial partners, including SMEs, with expertise in Liver Disease. Their goal is to design and validate a screening platform with biomarkers for population-wide use in Europe. The objective? Early identification of liver disease and personalized therapeutic interventions.

Professor Maja Thiele from the Center for Liver Research at OUH says about the project,
"We hope that with the LIVERAIM project, we can significantly improve the health and lives of liver patients. This is partly by providing doctors and nurses with accurate tests to detect liver disease early and partly by offering tailored treatment to individuals with chronic liver damage. The project is unique because, for the first time, we will test whether early detection results in fewer people becoming ill and dying from liver disease. In this way, it is a significant step for public health."

Here’s how LIVERAIM works:
1. Biomarker Testing: Existing biomarkers will be evaluated for their accuracy in predicting fibrosis. This analysis will involve 30,000 plasma samples from previously H2020 EU-funded cohorts.
2. AI-Powered Screening Platform: Using Artificial Intelligence (AI), the partners will develop a screening platform for personalized early diagnosis of liver fibrosis.
3. Validation: The platform will be rigorously validated in a randomized controlled trial (RCT) involving 100,000 subjects from six representative EU countries.
4. Tailored Interventions: The platform will link to personalized therapeutic interventions, aiming to halt fibrosis progression.

Medical and Ph.D. student on the project, Stine Johansen, says,
"It's an honor for us to be entrusted with such a large and unique study. With 100,000 participants from six European countries, it will be a project that can change the practice for doctors throughout Europe and redefine how we should find patients long before they are at risk of developing serious complications."

By enabling early diagnosis and personalized interventions, LIVERAIM aims to reduce morbidity, mortality, and the associated economic and health inequities related to liver disease. 

Project finances in numbers:
The total project size is 24.8 million euros, equivalent to almost 185 million DKK. The EU contributes €13.85 million, while pharmaceutical and medtech companies contribute the rest.
The Center for Liver Research at Odense University Hospital (OUH) receives €3.34 million, equivalent to 24.87 million DKK.

This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101132901. The JU receives support from the European Union’s Horizon Europe research and innovation programme and EFPIA, COCIR, MedTech Europe, Vaccines Europe and EuropaBio.

Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.