German SLD-Registry Registry for the characterization of patients with steatotic liver disease (SLD) in Germany

German SLD-Registry Registry for the characterization of patients with steatotic liver disease (SLD) in Germany - SLD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040904

Enrollment

15000

Registered

2026-07-10

Start date

2026-07-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLD (K76.-), MASLD, MASH, ALD (K70.-), MetALD K76 K70

Interventions

Group 1: Documentation of the natural course of steatotic liver diseases as well as the safety and effectiveness of approved MASLD/MASH medications. Physical examination and vital signs (e.g., weigh

comorbidities (e.g., diabetes, heart attack)

MASLD/MASH medication and medication for treating diseases related to SLD

concomitant medication

lab values (e.g., AST, ALT, creatinine, cholesterol)

genetic variants (e.g., PNPLA3)

liver diagnostics (e.g., histological findings, ultrasound findings, liver stiffness measurement)

lifestyle (e.g., alcohol consumption, physical activity)

quality of life (EQ-5D-5L questionnaire).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Typical imaging findings of hepatic steatosis (ultrasound, CAP, computed tomography, magnetic resonance imaging); Assessment of fibrosis stage using a non-invasive test (NIT); Presence of signs of metabolic syndrome; Credible assessment of alcohol consumption; Availability of a written informed consent form

Exclusion criteria

Exclusion criteria: Participation in clinical interventional studies (for the duration of study participation); patients whose MASLD/MASH treatment is documented in another compensated non-interventional study cannot simultaneously be documented in the German SLD-Registry; unwillingness or inability to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
Treated MASLD/MASH patients: Effectiveness (proportion of patients experiencing demonstrable improvement in MASLD/MASH based on histological or non-invasive methods). Untreated patients: Natural history of SLD (progression of liver fibrosis (MALO), cardiovascular events (MACE), malignancies).	—

Secondary

Measure	Time frame
Treated MASLD/MASH patients: Safety and tolerability, serious adverse events during therapy and subsequent follow-up. Progression of liver fibrosis (MALO), cardiovascular events (MACE), malignancies. Impact of successful therapy on morbidity and mortality. Patient-relevant parameters (quality of life). Untreated patients: Effectiveness of therapy for SLD-associated conditions (concomitant medication). Identification of clinically relevant risk markers regarding disease progression.	—

Measure

Time frame

Treated MASLD/MASH patients: Safety and tolerability, serious adverse events during therapy and subsequent follow-up. Progression of liver fibrosis (MALO), cardiovascular events (MACE), malignancies. Impact of successful therapy on morbidity and mortality. Patient-relevant parameters (quality of life). Untreated patients: Effectiveness of therapy for SLD-associated conditions (concomitant medication). Identification of clinically relevant risk markers regarding disease progression.

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026