Steatotic Liver DiseaseNCT04721665
German SLD-Registry (Deutsches SLD-Register)
An observational study of Steatotic Liver Disease, run by Leberstiftungs-GmbH Deutschland at 14 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Steatotic Liver Disease
- How many people
- 1,681 participants
- Where
- 14 sitesGermany
- Study dates
- 1 Dec 2020to 16 Apr 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The number of patients to be enrolled with SLD is limited to 10,000.
Who may be able to join
- diagnosed SLD based on the following criteria:
- typical finding of hepatic steatosis (abdominal ultrasound and/or pathological CAP value (latter is optional)
- Evaluation of SLD degree by NAFLD Fibrosis score and/or FIB-4-Index and/or transient elastography
- Evaluation of metabolic syndrome
- credible assessment of alcohol consumption
- written informed consent
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Infektiologisches Zentrum Steglitz
Berlin
Leber- und Studienzentrum Checkpoint
Berlin
MVZ für Gastroenterologie am Bayerischen Platz
Berlin
Praxis für Innere Medizin mit Schwerpunkt Gastroenterologie Dr. med. Jeannette Schwenzer
Berlin
MVZ Viszeralmedizin GmbH
Cologne
Praxis Ludwig und Dikopoulos
Dornstadt
Fachinternistische Schwerpunktpraxis
Hamburg
Gastroenterologische Studiengesellschaft Herne
Herne
Leberstudienzentrum Kiel
Kiel
Eugastro GmbH
Leipzig
MVZ Dres. Eisenbach,Simon, Schwarz GbR
Leverkusen
Praxis Dr. med. Kerstin Stein
Magdeburg
CIM GmbH
Münster
St. Josefs-Hospital Medizinische Klinik II
Wiesbaden
About this study
Official title: German SLD-Registry Characterization of Patients With Steatotic Liver Disease (SLD) in Germany - Phase 1 (Observation of the Natural Course)
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
- Steatotic Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLD patients | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of liver fibrosis
Fibrosis stage is measured by elastography (elastometry kPa value).
Measured: 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.)
Measured: through study completion, an average of 1 year
Cardiovascular events
The onset of the clinical outcome cardiovascular events (yes/no)
Measured: through study completion, an average of 1 year
Tumor diseases
The onset of the clinical outcome tumor diseases (yes/no)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Dec 2020
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,681 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Leberstiftungs-GmbH Deutschland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Zeuzem, Prof. Dr., Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721665
- Sponsor's protocol ID
- NAFLD_01
- Status last verified
- May 2026
- First submitted
- 30 Nov 2020
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German SLD-Registry Characterization of Patients With Steatotic Liver Disease (SLD) in Germany - Phase 1 (Observation of the Natural Course)
- ClinicalTrials.gov ID
- NCT04721665
- Acronym / sponsor ID
- NAFLD_01
- Conditions
- Steatotic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,681 participants (actual)
- Lead sponsor
- Leberstiftungs-GmbH DeutschlandIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLD patients | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The number of patients to be enrolled with SLD is limited to 10,000.
Key inclusion criteria (6 listed)
- diagnosed SLD based on the following criteria:
- credible assessment of alcohol consumption
- written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of liver fibrosis
Time frame: through study completion, an average of 1 year
Fibrosis stage is measured by elastography (elastometry kPa value).
Activity of metabolic dysfunction-associated steatohepatitis (MASH)
Time frame: through study completion, an average of 1 year
Activity is measured via histology (NAFLD activity score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8.)
Cardiovascular events
Time frame: through study completion, an average of 1 year
The onset of the clinical outcome cardiovascular events (yes/no)
Tumor diseases
Time frame: through study completion, an average of 1 year
The onset of the clinical outcome tumor diseases (yes/no)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Related information on the registryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zeuzem, Prof. Dr. principal investigator
Johann Wolfgang Goethe University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatotic Liver Disease, run by Leberstiftungs-GmbH Deutschland at 14 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of liver fibrosis (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.