Global Study to Identify and Manage Patients at Risk of Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis Using Non-Invasive Tests Across 10 European Countries

What this Trial Is About

Researchers are investigating metabolic dysfunction-associated steatotic liver disease MASLD and its progressive form metabolic dysfunction-associated steatohepatitis MASH in patients who are at high risk due to conditions like type 2 diabetes, metabolic syndrome, obesity, or arterial hypertension. The study aims to implement a patient care pathway across primary care centers in 10 European countries to identify those with MASLD and MASH, while raising awareness among healthcare providers. This observational research will help understand the prevalence and progression of these liver conditions through non-invasive testing and biomarker analysis. The study will screen 10,000 high-risk patients using at least two non-invasive tests, including FIB-4 and FibroScan, to detect liver steatosis, fibrosis, and at-risk MASH. Additional tests and analyses, such as blood samples and liver biopsies, will be collected for genomic, proteomic, metabolomic, lipidomic, and fluxomic studies to better understand disease mechanisms and identify markers for early detection. The study also compares the predictive value of different tests and investigates variations between participating countries. Participants will undergo initial screening and testing at baseline, with some receiving a second FibroScan at 14 weeks and a subset undergoing liver biopsy at 16 or 30 weeks. Blood samples and patient-reported outcomes on diet and lifestyle will be gathered throughout the study. A follow-up period of five years will monitor disease progression and help identify prognostic factors and biomarkers. The primary measurements include prevalence of liver conditions estimated by FibroScan and FAST score, with long-term observation of changes in liver health and associated complications.

Global Research Initiative for Patients Screening on MASH