Study of Non-Invasive Blood and Imaging Tests to Diagnose and Stage Metabolic Liver Disease NIMBLE Study 2.0 by the Foundation for the National Institutes of Health

What this Trial Is About

Researchers are evaluating non-invasive blood and imaging tests to diagnose and stage Metabolic dysfunction-associated steatohepatitis MASH, formerly known as nonalcoholic steatohepatitis NASH. This condition involves liver inflammation and fat buildup. The goal is to find safer alternatives to liver biopsy, which is invasive and carries risks. This study is part of the NIMBLE project, a collaboration including the Foundation for the National Institutes of Health FNIH, the FDA, academics, and industry partners, aiming to qualify biomarkers for MASH diagnosis and staging. The study focuses on confirming and expanding previous findings from NIMBLE Stage 1 by evaluating blood-based, Vibration Controlled Transient Elastography VCTE-based, and imaging biomarkers in a prospective, non-interventional trial. These biomarkers are compared against liver biopsy results and existing diagnostic tools in people at risk for MASH with fibrosis. This research seeks to support regulatory approval of one or more biomarker tests or panels. Participants will be assessed within 120 days of enrollment for key outcomes including detection of at-risk MASH, fibrosis staging, liver fat content, diagnostic enrichment, and exploratory biomarkers. Additional evaluations compare these biomarkers to fibrosis-related standards, liver enzyme activity, histology, and AI-driven histology endpoints. The study involves informed consent, compliance with procedures, and various assessments to monitor liver health and biomarker performance over the study duration.

Evaluation of Non-Invasive Tests for Metabolic Liver Disease