Assessment of Non-Invasive Testing in Major Liver-Related Outcomes (NCT06986447) | Clinical Trial Compass
By InvitationNot Applicable
Assessment of Non-Invasive Testing in Major Liver-Related Outcomes
United States1,689 participantsStarted 2025-10-25
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Adults, 18-80, male or female.
✓. 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.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (including sponsors, clinic staff, and vendors)
✕. Participation in another clinical study with intake of an investigational product during the last 60 days prior to Baseline
✕. Participation in a large multinational observational cohort (local registry and biobank are allowed) Target disease exclusions
✕. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to baseline (For Cohort A only).
✕. MELD score ≥12, as determined at baseline, due to liver disease.
✕. Evidence of current, chronic liver diseases at the time of baseline: