Assessment of Non-Invasive Testing in Major Liver-Related Outcomes

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.

NCT Number	NCT06986447
Lead Sponsor	HRI-MAIL-NIT
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), MetALD
Enrollment	1,689 participants
Start Date	2025-10-25
Primary Completion	2029-02 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-27