Actively Recruiting
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
Led by Foundation for the National Institutes of Health · Updated on 2025-08-14
400
Participants Needed
4
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.
CONDITIONS
Official Title
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and available for study duration
- Male or female aged over 18 and under 75 years
- Exhibit metabolic dysfunction defined by either physician-diagnosed type 2 diabetes mellitus for at least 90 days with HbA1c > 6.5 and stable antidiabetic therapy, or at least one metabolic syndrome criterion: BMI > 25 kg/m2, waist circumference >102 cm for men or >88.9 cm for women, fasting triglycerides >150 mg/dL or treatment for triglycerides, HDL cholesterol <40 mg/dL for men or <50 mg/dL for women or cholesterol-lowering treatment, fasting glucose >100 mg/dL, or blood pressure systolic >130 mmHg or diastolic >85 mmHg or treatment for hypertension
- FIB-4 score >1.3 if under 65 years old or >2.0 if over 65 years old
- 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 B or C, autoimmune liver diseases, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, bile duct obstruction, liver cancer, prior hepatocellular carcinoma or treatment, liver transplant history, or liver resection
- Current or past decompensated liver disease with symptoms requiring therapy such as ascites, encephalopathy, or variceal bleeding
- Alanine aminotransferase (ALT) level greater than five times the upper limit of normal
- Significant alcohol use exceeding defined moderate levels in the past two years or Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher or PEth test ≥ 20 ng/ml
- Contraindications to liver biopsy such as significant uncorrected bleeding risk or anticoagulation therapy
- Uncontrolled blood pressure above 180/120 mmHg at screening
- Any systemic disease preventing participation as judged by the investigator
- Unable or unwilling to give informed consent or undergo liver biopsy
- Inability or unwillingness to comply with study procedures including fasting
- Unable to complete study procedures as judged by the investigator
- Inability or unwillingness to undergo MRI due to implants or waist size over 70 cm without wide-bore MRI
- Pregnancy or planned pregnancy within 4 months of screening
- 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
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
CONTACT
C
Clay Dehn
CONTACT
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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