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AI-Powered liver test could spot hidden risks in fatty liver patients

NCT ID NCT06344364

Diagnosis Sponsor: PharmaNest, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 3 times

Summary

This study looked at over 1,200 adults with metabolic fatty liver disease (MASLD) to see if a new digital test, called FibroNest Ph-FCS, can predict who will develop serious liver complications. The test uses computer analysis of standard liver biopsy images to measure scarring. If proven accurate, it could give doctors a better tool to identify high-risk patients and guide treatment decisions.

What this could mean

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

Active substance
Digital pathology test (FibroNest Ph-FCS) analyzing liver biopsy images
What this could lead to
If successful, this test could help doctors better predict which MASLD patients are at risk of serious liver problems, enabling earlier intervention.
What could go wrong
This is a retrospective study, not a treatment trial. The test may not be accurate enough in real-world settings or for 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

1,241 people

The number who actually took part.

Started

Sep 2025

Finished

Aug 2026

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

Adult pts ( \>=18 years old) with MASLD defined histologically with \>1 year of clinical follow up and available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation.

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: * Adult pts ( \>=18 years old) with MASLD defined histologically. * Liver biopsy with fibrosis stains available for digitization or already digitized. * Clinical follow-up \>1 year available recording liver-related outcomes either through hospitalization ICD-10 codes or through clinical observation Exclusion Criteria: * Liver diseases other than MASLD Note: no exclusion based on bariatric surgery, significant weight loss or enrollment in NASH clinical studies, but data is collected for data analysis / competing effects (see data analysis plan)

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Conditions

The condition(s) this trial relates to.

liver disorder 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.

Metabolic dysfunction-associated steatotic liver disease

Contacts and locations

Locations

  • Fundació de Recerca Clinic Barcelona

    Barcelona, Spain

  • The Chinese University of Hong Kong

    Shatin, Hong Kong

  • University of Seville

    Seville, 41004, Spain

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