HRI-MAIL-NIT
This is a general clinical research protocol to study the clinical evaluation, investigation and long-term follow up of patients who have Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and MetALD (MASLD and increased alcohol intake), and to assess the usefulness and accuracy of non-invasive testing such as MRI and Fibroscan in tracking the progression of disease. The protocol is designed to follow the natural history, pathogenesis, interventions, treatment response, comorbidities, major liver related outcomes, and major cardiac events in patients with MASLD and MetALD, especially those with significant and advanced fibrosis. Data will be collected to help further the understanding of non-invasive testing with the hopes of lessening the need for liver biopsies in phase 3 clinical trials of MASLD and in clinical practice. Additionally, the study will aim to define the natural history of MetALD, an area that is poorly understood.
Inclusion Criteria: \- Inclusion Criteria: 1. Adults, 18-80, male or female. 2. Cohort A (MASH): Evidence of MASH (metabolic dysfunction-associated steatohepatitis) with fibrosis stage 3 or higher based on MRE stiffness of \>3.63 kPa or liver biopsy. Cohort B (MetALD): Evidence of MetALD/ALD as defined by the AASLD nomenclature criteria and evidence of liver stiffness of 12 kPa or higher on VCTE. 3. Willingness to participate in the study. Exclusion criteria <!-- --> 1. Involvement in the planning and/or conduct of the study (including sponsors, clinic staff, and vendors) 2. Participa…