MASLD/MASH
Conditions
Brief summary
This retrospective multicentre cohort study will use existing medical records from adults with Metabolic Dysfunction-Associated Steatotic Liver Disease or Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) who underwent two Vibration-Controlled Transient Elastography-Liver Stiffness Measurement (VCTE-LSM) (FibroScan) assessments during routine clinical care. The study will evaluate whether changes in fibrosis risk tier between the two assessments are associated with future major liver-related outcomes and all-cause mortality. The duration of study will be 5 months.
Interventions
This is a retrospective observational cohort study. The data will be collected via EMR.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older at the cohort entry date. * At least two VCTE examinations during the data period, with the interval between the first and second VCTE between 1 year and 5 years (both inclusive). * Diagnosis of MASLD, defined as the coexistence of hepatic steatosis confirmed by histology, imaging, or VCTE-Controlled Attenuation Parameter (CAP) more than or equal to (≥) 248 decibels per meter (dB/m), and at least one cardiometabolic criterion, in accordance with the Multi-society MASLD nomenclature consensus.
Exclusion criteria
* Prior history of hepatocellular carcinoma at any time before index date. * Prior history of decompensated cirrhosis (any of: bleeding oesophageal varices, ascites, hepatic encephalopathy, hepatorenal syndrome) at any time before index date. * Prior history of liver resection or transplantation at any time before index date. * Prior diagnosis of any extrahepatic malignancy at any time before index date. * Occurrence of any MALO component (HCC, complication of liver cirrhosis, liver transplantation, or death) within 6 months after the index date. * Antiviral treatment for hepatitis B or hepatitis C virus initiated more than 3 months before the index date and ongoing through the index date. * Total post-index follow-up duration of less than 6 months. * Insufficient medical record data preventing operationalisation of key study variables.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of decompensated cirrhosis | From index date (second VCTE and start of follow-up) to the first occurrence of major adverse liver outcome (MALO) (up to 31 Dec 2025) | Confirmed by referring to histology, imaging (e.g., abdominal ultrasound, computed tomography, or magnetic resonance imaging) reports. Primary endpoint will be presented with composite outcome. |
| Occurrence of hepatocellular carcinoma (HCC) confirmed by imaging or biopsy | From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025) | Confirmed by imaging or histological confirmation in the medical record. Primary endpoint will be presented with composite outcome. |
| Liver transplantation | From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025) | Operationalised as liver transplantation, identified by transplant procedure code or EMR documentation. Chronic liver failure not requiring transplantation is not separately ascertained and is captured within the decompensated-cirrhosis component. Primary endpoint will be presented with composite outcome. |
| All-cause death | From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025) | Documented in the EMR or via linkage to administrative records where available. Primary endpoint will be presented with composite outcome. |
Countries
South Korea
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed