NCT07739901Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 13 Jul 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07739901
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 13 Jul 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Total post-index follow-up duration of less than 6 months.
- Insufficient medical record data preventing operationalisation of key study variables.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novo Nordisk Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.