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Needle-Free hope: new blood test may detect liver scarring without painful biopsy

NCT ID NCT06819917

Diagnosis Sponsor: Roche Diagnostics GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is collecting blood samples from 575 adults with fatty liver disease to find new, noninvasive tests that can detect liver scarring (fibrosis). Currently, doctors rely on a painful liver biopsy to check for scarring, but this research aims to replace that with a simple blood test. Participants will give blood and may also have a noninvasive ultrasound scan. The goal is to make diagnosis easier, safer, and more accessible for millions of people with fatty liver disease.

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 575 people

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

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients will be recruited in the study using 2 different approaches. The first is patients who are referred to clinical centers as part of an existing assessment where a decision to perform a liver biopsy has been made. This decision can be based on standard liver function tests AST, ALT, FIB-4 , fibroscan or other factors. In addition, patients F0-F2 who underwent a biopsy within the last 6 months but at least 1 month ago, can be recalled to join the study. If patients agree to participate in the study, they will be recalled to the site for a blood draw and ultrasound scan (if patients consent for further use, to be performed latest 6 months after biopsy).

Ages

18 to 75 years

Sex

Anyone

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: * Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL/NASH) or patients with MASLD or MASH * Any FIB-4 value available * Any Fibroscan value available * Written and signed informed consent present * Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw * Body Mass Index (BMI) ≤ 45 kg/m² Exclusion Criteria: * Vulnerable person: person deprived of liberty by a judicial or administrative decision and/or person under psychiatric care * Self-reported pregnancy or lactating females * Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency * Any type of carcinoma, unless it is at least 5 years in remission * Prior liver transplant * Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed * Self-reported alcohol consumption greater 30 g/day (males) 20 g/day (females) * Recent myocardial infarction (within last 6 months) * Inability to have a liver biopsy, or provide blood sample in a fasted status * F0-F2 recalled patients with +/- 5% change in weight between the biopsy and study inclusion

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Non - alcoholic steatohepatitis Non alcoholic fatty liver Non-alcoholic fatty liver disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hvidovre Hospital

    RECRUITING

    Copenhagen, Denmark

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    RECRUITING

    Mainz, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.