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Can a liver drug also protect the heart? study tests ursodeoxycholic acid in fatty liver disease

NCT ID NCT05256979

Disease control Sponsor: General University Hospital, Prague 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers at a Prague hospital are observing whether ursodeoxycholic acid, a drug used for certain liver conditions, affects liver fat, liver enzymes, and markers of heart and blood vessel health in people with non-alcoholic fatty liver disease. The study includes 20 adults who have fatty liver with elevated liver enzymes and signs of bile flow problems, and who are already prescribed the drug by their doctor. Participants undergo blood tests, liver scans, and heart assessments before treatment and again after six months. The goal is to see whether the drug changes these measurements, which could inform larger studies.

What this could mean

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

Active substance
ursodeoxycholic acid
What this could lead to
If the treatment changes liver fat or heart risk markers, this could support larger studies of ursodeoxycholic acid for fatty liver disease.
What could go wrong
This is a small observational pilot with 20 people, so it cannot prove cause and effect. Any changes seen may be due to other factors, and the results may not apply to everyone 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 20 people

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

Started

Jul 2022

Expected to finish

Nov 2026

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

Patients with NAFLD

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: * Individuals with NAFLD with ALT elevation and cholestatic features who are indicated for standard treatment with ursodeoxycholic acid according to SPC ("Hepatitis of various etiologies with cholestatic syndrome"). Exclusion Criteria: * Previous treatment with ursodeoxycholic acid. * Diagnosis of cirrhosis at the start of the study. * Etiology of liver disease other than NAFLD. * Presence of malignant disease. * Cardiovascular comorbidity: CHD / CHD on pharmacological therapy, history of myocardial infarction, stroke and coronary / carotid intervention. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease 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 fatty liver disease

Contacts and locations

Locations

  • General University Hospital

    Prague, 12808, Czechia

More trials for these conditions

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