Fatty liver disease (NASH/MASH)

Evaluation of Non-Invasive Tests for Metabolic Liver Disease

Recruiting · 4 sites across 3 states

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults with metabolic problems related to liver disease, including either T2DM or at least one metabolic syndrome sign (like higher waist size, higher triglycerides, low HDL, higher fasting sugar, or high blood pressure).
•Men or women age over 18 and under 75.
•People who agree to follow all study steps for the whole study and can be available for the full duration.
•People who can provide informed consent.
•People willing and able to do required procedures such as fasting, liver biopsy, and MRI.

🚫 You may not be able to join if…

•People with other long-term liver diseases (like viral hepatitis B/C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, bile duct blockage, or liver cancer, including past HCC or liver transplant).
•People with “decompensated” liver disease signs such as obvious fluid buildup (ascites needing diuretics), confusion/encephalopathy needing treatment, or past bleeding from enlarged veins (variceal hemorrhage).
•People with very high ALT (more than 5 times the upper limit of normal).
•People with heavy alcohol use (above defined limits or certain positive screening tests like AUDIT ≥ 7 or PEth ≥ 20 ng/ml).
•Pregnant or planning pregnancy within 4 months of screening; also those unable/unwilling for consent, liver biopsy, required procedures (including MRI), or unable to comply with study requirements.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18–75
✓Have Obesity / overweight or Type 2 diabetes

!Some conditions may not be a fit: Fatty liver disease (NASH/MASH)
!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. This study may also compensate you for your time and travel — the team will tell you the amount before you join. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT07122700 · Locations: Florida · Ohio · Texas