Korean Real-world Study on MASLD/MASH Outcomes.

NCT07739901 | Active Not Recruiting

• 2 other identifiers: NN9931-8923U1111-1342-6447
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

MASLD/MASH

Outcome Measures

Primary Outcomes (4)

• Occurrence of decompensated cirrhosis

  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.

  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)

• Occurrence of hepatocellular carcinoma (HCC) confirmed by imaging or biopsy

  Confirmed by imaging or histological confirmation in the medical record. Primary endpoint will be presented with composite outcome.

  From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)

• Liver transplantation

  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.

  From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)

• All-cause death

  Documented in the EMR or via linkage to administrative records where available. Primary endpoint will be presented with composite outcome.

  From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)

Study Arms (1)

cohort with MASLD/MASH

Adults with MASLD/MASH who had at least two VCTE-LSM assessments performed 1 to 5 years apart during routine clinical care. Medical records will be reviewed to assess the association between changes in VCTE-LSM risk tier and long-term clinical outcomes.

Other: No treatment is given

Interventions

No treatment is given OTHER

This is a retrospective observational cohort study. The data will be collected via EMR.

cohort with MASLD/MASH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises Korean adults aged 18 years or older who received at least two VCTE examinations at participating Korean tertiary hospitals during the data period.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Seoul, South Korea

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)