Active, Not Recruiting

NCT Number: NCT07739901

Korean Real-world Study on MASLD/MASH Outcomes.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

MASLD/MASH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No treatment is given

Other

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

Primary outcomes

Occurrence of decompensated cirrhosis

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 31, 2026
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.