Korean Real-world Study on MASLD/MASH Outcomes.

Linking Surrogate Endpoints to Long-term Final Outcomes in MASLD/MASH: A Korean Multicentre Real-World Evidence Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: MASLD/MASH
• Intervention / Treatment: Other: No treatment is given

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This is a retrospective observational cohort study. The data will be collected via EMR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NN9931-8923; U1111-1342-6447 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No