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New blood tests could replace painful liver biopsies for millions with fatty liver disease

NCT ID NCT03695796

Diagnosis Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at over 1,000 people with non-alcoholic fatty liver disease (NAFLD) to see if simple blood tests and ultrasound-based devices can accurately detect liver scarring (fibrosis) without needing a liver biopsy. The goal is to develop reliable, non-invasive tools to identify patients who may benefit from future treatments. Participants had liver biopsies to confirm their condition and also underwent various non-invasive tests for comparison.

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 successful, this could lead to reliable non-invasive tests to identify NAFLD patients who need treatment, avoiding the need for liver biopsies.
What could go wrong
This is an observational study, not a treatment trial. The tests may not be accurate enough to replace biopsy in all cases, 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,005 people

The number who actually took part.

Started

Nov 2018

Finished

Jun 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: * NAFLD diagnosis defined by the presence of at least two of the following elements: * Liver steatosis (hyperechoic liver on hepatic ultrasound, quantification \> 5.6 % by spectroscopy or MRI) * Presence of one metabolic risk factor: * BMI ≥ 25 kg/m2 or waist circumference ≥ 94 cm (male) / ≥ 80 cm (female) * Antihypertensive treatment or systolic BP ≥ 130 mmHg or diastolic BP ≥ 85 mmHg * Antidiabetic treatment or fasting blood glucose ≥ 5.6 mmol/l * Lipid-lowering treatment or triglycerides ≥ 1.71 mmol/l or HDL cholesterol \<1.1 mmol/l (male) / \<1.3 mmol/l (female) * Dysmetabolic hyperferritinemia * Anomaly in the liver enzyme test or liver function tests * Indication for liver biopsy in the clinical management of the patient * Obtaining the signature of the consent to participate in the study Exclusion Criteria: * Steatogenic treatment (corticosteroids, tamoxifen, amiodarone, methotrexate) * Excessive alcohol consumption in the last 5 years (\> 210 g / week for men or \> 140 g / week for women) * Chronic infection with hepatitis B or C * Any evidence of other concomitant chronic liver disease * Decompensated cirrhosis (ascites, digestive bleeding due to varicose vein rupture, liver failure, hepatocellular failure, hepato-renal syndrome) * Hepatocellular carcinoma * Pregnant, breastfeeding or parturient women * Persons deprived of their liberty by judicial or administrative decision * Persons subject to legal protection measures * Persons unable to consent * Refusal to participate

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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.

NAFLD

Contacts and locations

Locations

  • Amiens University Hospital

    Amiens, France

  • Edouard Herriot Hospital

    Lyon, France

  • Grenoble University Hospital

    Grenoble, France

  • Hospital Center Of Lorient

    Lorient, France

  • Hospital of Le Havre

    Le Havre, France

  • Saint-Joseph Hospital

    Marseille, France

  • University Hospital Of Nancy

    Vandœuvre-lès-Nancy, France

  • University Hospital Of Nice

    Nice, France

  • University Hospital of Besançon

    Besançon, France

  • University Hospital of Clermont-Ferrand

    Clermont-Ferrand, France

  • University Hospital of Lille

    Lille, France

  • University Hospital of Pointe à Pitre

    Pointe-à-Pitre, Guadeloupe

  • University Hospital of Rouen

    Rouen, France

  • University Hospital of Strasbourd

    Strasbourg, France

  • University Hospital of Toulouse

    Toulouse, France

  • University of Bordeaux

    Pessac, France

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