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Simple blood test may spot hidden liver damage in obesity

NCT ID NCT07663188

Diagnosis Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a common blood test called FIB-4 can accurately predict liver fibrosis (scarring) in people with obesity. Researchers will compare FIB-4 results with liver stiffness measurements from a specialized scan (FibroScan) in 400 obese patients. If the blood test works well, it could help identify those who need further liver evaluation without unnecessary procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If FIB-4 proves accurate, it could become a standard first-step test to identify liver fibrosis in obese patients without needing immediate specialized scans.
What could go wrong
This is an observational study, not a treatment trial. The FIB-4 test may not be accurate enough to replace current methods, and results may not apply to all patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive adult obese patients (BMI ≥ 30 and ≤ 40 kg/m²), aged 18-64 years, attending the outpatient Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis" (Castellana Grotte, Italy). Patients are enrolled during a Day Service access in which routine blood tests and liver stiffness measurement by FibroScan are performed as part of standard clinical practice. Patients are stratified into two cohorts based on FIB-4 score: Cohort 1 (FIB-4 ≥ 1.3) and Cohort 2 (FIB-4 \< 1.3). Patients with known liver diseases other than MASLD, pregnancy, or current treatment with GLP-1 receptor agonists known to affect hepatic steatosis (Semaglutide or Tirzepatide) are excluded

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Obesity class I or II (body mass index, BMI ≥ 30 kg/m² and ≤ 40 kg/m²) * Age \> 18 years and \< 65 years. * Ability to provide written informed consent after adequate information on the study objectives. * Arm 1: patients with FIB-4 ≥ 1.3. * Arm 2: patients with FIB-4 \< 1.3. Exclusion Criteria: * Lack of signed informed consent. * Pregnancy or breastfeeding. * Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis). * Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MASLD

How to take part

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  1. The official record

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