Korean Real-world Study on MASLD/MASH Outcomes. | NCT07739901

NCT07739901

Overview

NCT ID: NCT07739901
Lead Sponsor: Novo Nordisk A/SINDUSTRY
Official Title: Linking Surrogate Endpoints to Long-term Final Outcomes in MASLD/MASH: A Korean Multicentre Real-World Evidence Study
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

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Jul 13, 2026Actual
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Observational
Phase: No data available
Enrollment: 10,000Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Novo Nordisk Investigational Site

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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