Assessment of Non-Invasive Testing in Major Liver-Related Outcomes
NCT06986447 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1689
Last updated 2026-03-27
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.
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
Sponsors & Collaborators
-
HRI-MAIL-NIT
lead INDUSTRY
Principal Investigators
-
Mazen Noureddin, MD, MHSc · Houston Research Institute
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-25
- Primary Completion
- 2029-02-28
- Completion
- 2029-06-30
Countries
- United States
Study Locations
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