NCT06986447

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

MASH/MetALD Consortium for the Assessment of Non-Invasive Testing in Monitoring Interventions, Treatment Response, and Major Liver-Related Outcomes

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,689 (estimated)
• Sponsor: HRI-MAIL-NIT · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-10-25
• Primary completion: 2029-02-01
• Completion: 2029-06-01
• First posted: 2025-05-23
• Last updated: 2026-03-27

Locations

8 sites across 1 country: United States