Evaluation of Non-Invasive Tests for Metabolic Liver Disease
This study, called NIMBLE, is looking for better ways to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH. MASH is a liver condition where fat builds up and causes inflammation. Currently, a liver biopsy is the most accurate test, but it's invasive. This study aims to find and validate non-invasive tests, like blood tests and imaging, that can replace biopsies. Researchers will be looking for specific biomarkers (biological indicators) to detect MASH, stage liver fibrosis (scarring), and monitor liver fat. You may be able to join if you are between 18 and 75 years old and have certain signs of metabolic problems, such as physician-diagnosed Type 2 Diabetes (T2DM) for at least 90 days with an HbA1c (a measure of blood sugar) greater than 6. This is an observational study, meaning no new treatments are being tested. The study is planning to enroll 400 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 400 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will be involved for up to 120 days. Specific procedures or visits are not detailed in the record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 120 days after study enrollment to measure primary endpoints.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
At a glance
Conditions
NCT07122700
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Clinical Pharmacology of Miami
Miami, Floridastudy coordinator listed
Recruiting
Endeavor Clinical Trials
San Antonio, Texasstudy coordinator listed
Recruiting
First Surgical Hospital
Bellaire, Texasstudy coordinator listed
Recruiting
Ohio Clinical Trials
Columbus, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Arun Sanyal · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
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Exclusion
What this trial measures
- Detection of At-Risk MASHwithin 120 days of study enrollment.
Evaluate the diagnostic performance of individual and combined biomarkers (e.g., NIS2+, ADAPT \[PRO-C3-based score\], MRI-AST (MAST) \[MRE + PDFF + AST\], FAST and Metabolomics-Advanced Steatohepatitis Fibrosis (MASEF) \[included in the OWLiver Test\]) for identifying at-risk MASH (MASH + MAS ≥4 + fibrosis stage ≥2).
- Fibrosis Stagingwithin 120 days of study enrollment.
Assess blood-based, imaging, and composite biomarkers (e.g., Enhanced Liver Fibrosis (ELF) Test, Liver Stiffness Measure (LSM) by VCTE, MRE, Agile 3+, Agile 4) for detecting clinically significant fibrosis (≥2), advanced fibrosis (≥3), and fibrosis stage 4 (cirrhosis, histologically defined).
- Liver Fat Content Monitoringwithin 120 days of study enrollment.
Evaluate imaging-based biomarkers (e.g., MRI-PDFF, Hepatorenal Index, Controlled Attenuation Parameter (CAP)) for hepatic steatosis monitoring.
- Diagnostic Enrichmentwithin 120 days of study enrollment.
Identify biomarkers that enhance participant selection for clinical trials, focusing on populations with at-risk MASH, specific fibrosis stages, or steatosis.
- Exploratory Biomarkerswithin 120 days of study enrollment.
Investigate exploratory biomarkers (e.g., AI-based histological scoring, sequential testing strategies) for novel diagnostic workflows.