Actively Recruiting
Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study
Led by Foundation for the National Institutes of Health · Updated on 2025-08-14
400
Participants Needed
4
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent provided
- Willingness to comply with all study procedures and be available for the study duration
- Male or female aged over 18 and under 75 years
- Exhibits metabolic dysregulation such as physician-diagnosed type 2 diabetes for at least 90 days with stable treatment and HbA1c over 6.5, or at least one metabolic syndrome criterion (BMI > 25 kg/m2, waist circumference over 102 cm for men or 88.9 cm for women, fasting triglycerides over 150 mg/dL or treatment for triglycerides, low HDL cholesterol, fasting glucose over 100 mg/dL, elevated blood pressure or treatment for hypertension)
- FIB-4 score over 1.3 if under 65 years or over 2.0 if over 65 years
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- History or evidence of other chronic liver diseases besides MASLD/MASH, including viral hepatitis, autoimmune liver disease, bile duct conditions, liver cancer, prior liver transplant or resection
- Current or past decompensated liver disease requiring therapy for ascites, encephalopathy, or variceal bleeding
- Alanine aminotransferase (ALT) level greater than 5 times the upper limit of normal
- Significant alcohol consumption over the past 2 years exceeding defined limits or with high AUDIT or PEth test scores
- Contraindications to liver biopsy such as uncorrected coagulopathy or use of certain anticoagulants
- Uncontrolled high blood pressure at screening
- Any systemic disease preventing trial inclusion
- Unable or unwilling to give informed consent or comply with study procedures
- Unwillingness to undergo liver biopsy
- Inability to perform study procedures
- Inability or unwillingness to undergo MRI due to implants or body size
- Pregnancy or planned pregnancy within 4 months
- Participation in another clinical trial within 30 days or investigational drug use within 90 days prior to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 days
Participants undergo non-invasive blood-based, VCTE-based, and imaging biomarker tests, as well as liver biopsy to evaluate metabolic liver disease and fibrosis.
1 to 2 visits depending on biomarker and biopsy scheduling
Duration - Up to 120 days
Participants are observed after initial diagnostic testing to gather data on biomarker performance in diagnosing and staging metabolic liver disease.
Additional visits may occur depending on participant follow-up needs
Trial Site Locations
Total: 4 locations
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Actively Recruiting
2
Ohio Clinical Trials
Columbus, Ohio, United States, 43212
Actively Recruiting
3
First Surgical Hospital
Bellaire, Texas, United States, 77401
Actively Recruiting
4
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
G
Geraldine Dacpano
C
Clay Dehn
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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