CompletedNCT04721665Updated May 28, 2026

German SLD-Registry (Deutsches SLD-Register)

An observational study in Steatotic Liver Disease, sponsored by Leberstiftungs-GmbH Deutschland. Completed at 14 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Leberstiftungs-GmbH Deutschland · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,681
Ages: 18 Years and older
Sex: All

Study summary

Characterization of patients with steatotic liver disease (SLD)

The German SLD-Registry (Deutsches SLD-Register) a project of the German Liver Foundation (Deutsche Leberstiftung), managed by Leberstiftungs-GmbH Deutschland.

The German NAFLD-Registry is financially supported by: Advanz Pharma Specialty Medicine Deutschland GmbH und Gilead Sciences GmbH (Grant to German Livber Foundation) sowie Novo Nordisk Pharma GmbH (directly via Leberstiftungs-GmbH).

Read the detailed description

The following data can be documented:

physical examination and vital parameters (e.g. age, weight)
comorbidities (e.g. diabetes mellitus, cardiovascular disease)
comedication (treatment of comorbidities related to SLD)
laboratory values (e.g. liver function tests, creatinine)
genetic variants (e.g. PNPLA3)
liver diagnostics (e.g. histological findings, sonographic findings)
lifestyle (alcohol consumption, physical activity)
health related quality of life (SF-36 questionnaire)

Conditions studied

Steatotic Liver Disease

In context

Lead sponsor

This is the only study on the registry with Leberstiftungs-GmbH Deutschland as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,681 participants (actual)
Target follow-up: 6 Years
Patient registry: Yes

Groups and cohorts

SLD patients
No intervention

What researchers measure

Primary outcomes

Progression of liver fibrosis
Fibrosis stage is measured by elastography (elastometry kPa value).
Time frame: through study completion, an average of 1 year
Activity of metabolic dysfunction-associated steatohepatitis (MASH)
Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)
Time frame: through study completion, an average of 1 year
Cardiovascular events
The onset of the clinical outcome cardiovascular events (yes/no)
Time frame: through study completion, an average of 1 year
Tumor diseases
The onset of the clinical outcome tumor diseases (yes/no)
Time frame: through study completion, an average of 1 year

Study locations

14 sites

Infektiologisches Zentrum Steglitz
Berlin, Germany
Leber- und Studienzentrum Checkpoint
Berlin, Germany
MVZ für Gastroenterologie am Bayerischen Platz
Berlin, Germany
Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
Berlin, Germany
MVZ Viszeralmedizin GmbH
Cologne, Germany
Praxis Ludwig und Dikopoulos
Dornstadt, Germany
Fachinternistische Schwerpunktpraxis
Hamburg, Germany
Gastroenterologische Studiengesellschaft Herne
Herne, Germany
Leberstudienzentrum Kiel
Kiel, Germany
Eugastro GmbH
Leipzig, Germany
MVZ Dres. Eisenbach,Simon, Schwarz GbR
Leverkusen, Germany
Praxis Dr. med. Kerstin Stein
Magdeburg, Germany
CIM GmbH
Münster, Germany
St. Josefs-Hospital Medizinische Klinik II
Wiesbaden, Germany

References and documents

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04721665
Lead sponsor: Leberstiftungs-GmbH Deutschland
Responsible party: Sponsor
First posted: Jan 25, 2021
Start date: Dec 1, 2020
Primary completion: Apr 16, 2026
Completion: Apr 16, 2026
Last update: May 28, 2026

Study contacts

Stefan Zeuzem, Prof. Dr.

principal investigator · Johann Wolfgang Goethe University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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