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Thousands with fatty liver disease monitored to understand long-term risks

NCT ID NCT04721665

Knowledge-focused Sponsor: Leberstiftungs-GmbH Deutschland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study followed 1,681 people with steatotic liver disease (fatty liver) in Germany to observe how the condition progresses over time. Researchers measured liver stiffness, inflammation, and tracked whether participants developed heart problems or tumors. The goal was to better understand the natural course of the disease, not to test a new treatment.

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

1,681 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 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

The number of patients to be enrolled with SLD is limited to 10,000.

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: * diagnosed SLD based on the following criteria: 1. typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional) 2. Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography 3. Evaluation of metabolic syndrome * credible assessment of alcohol consumption * written informed consent Exclusion Criteria: * patients with other hepatologic diseases (chronically viral, metabolic, autoimmune origin * patients receiving hepatotoxic medications over a longer period (e.g. methotrexate, amiodarone, longterm NSAR intake) * malignant disease with a life expectancy \<12 months * participation in clinical interventional/pivotal studies * inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

alcoholic fatty liver disease fatty liver disease

As listed by the trial registrant

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

Steatotic liver disease

Contacts and locations

Locations

  • CIM GmbH

    Münster, Germany

  • Eugastro GmbH

    Leipzig, Germany

  • Fachinternistische Schwerpunktpraxis

    Hamburg, Germany

  • Gastroenterologische Studiengesellschaft Herne

    Herne, Germany

  • Infektiologisches Zentrum Steglitz

    Berlin, Germany

  • Leber- und Studienzentrum Checkpoint

    Berlin, Germany

  • Leberstudienzentrum Kiel

    Kiel, Germany

  • MVZ Dres. Eisenbach,Simon, Schwarz GbR

    Leverkusen, Germany

  • MVZ Viszeralmedizin GmbH

    Cologne, Germany

  • MVZ für Gastroenterologie am Bayerischen Platz

    Berlin, Germany

  • Praxis Dr. med. Kerstin Stein

    Magdeburg, Germany

  • Praxis Ludwig und Dikopoulos

    Dornstadt, Germany

  • Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer

    Berlin, Germany

  • St. Josefs-Hospital Medizinische Klinik II

    Wiesbaden, Germany

More trials for these conditions

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