Active — Not RecruitingNot Applicable

Korean Real-world Study on MASLD/MASH Outcomes.

South Korea10,000 participantsStarted 2026-07-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of decompensated cirrhosis

Timeframe: 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

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

Liver transplantation

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

All-cause death

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

Trial details

NCT IDNCT07739901

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More MASLD/MASH trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Occurrence of decompensated cirrhosis

Timeframe: 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

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

Liver transplantation

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

All-cause death

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