Sacele

Researchers are evaluating a care pathway to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH), across primary care centers and clinics in 10 European countries. This observational study will screen 10,000 high-risk patients, including those with type 2 diabetes, metabolic syndrome, obesity, or arterial hypertension, to raise awareness and implement the latest European Association for the Study of the Liver (EASL) recommendations. The study involves non-invasive testing using at least two assessments, FIB-4 and FibroScan, to detect MASLD, liver fibrosis, and at-risk MASH. Additional published and exploratory non-invasive tests will also be explored. Blood samples and liver biopsy materials will be collected for advanced studies such as genomic, proteomic, metabolomic, lipidomic, and fluxomic analyses to better understand MASLD's pathophysiology and discover biomarkers for identifying patients at risk. The predictive value of FIB-4 compared to FibroScan and liver biopsy will be analyzed. Participants will undergo screening at baseline to assess liver steatosis, fibrosis, and at-risk MASH using FibroScan and FAST scores, with some re-evaluated at 16 or 30 weeks. The study will compare findings across participating countries and evaluate a two-step detection pathway's added value compared to FibroScan alone. A long-term follow-up of five years will provide insight into the disease's natural history. Safety and disease progression will be monitored throughout the study period.