MASLD/MASHNCT07739901
Korean Real-world Study on MASLD/MASH Outcomes.
An observational study of MASLD/MASH, run by Novo Nordisk A/S at 1 site in South Korea.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD/MASH
- What is being tested?
- No treatment is given
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- MASLD/MASH
- Being tested
- No treatment is given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment is givenOther
This is a retrospective observational cohort study. The data will be collected via EMR.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No treatment is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From index date (second VCTE and start of follow-up) to the first occurrence of MALO (up to 31 Dec 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start13 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD/MASHStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739901
- Sponsor's protocol ID
- NN9931-8923
- Other IDs
- U1111-1342-6447
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Surrogate Endpoints to Long-term Final Outcomes in MASLD/MASH: A Korean Multicentre Real-World Evidence Study
- ClinicalTrials.gov ID
- NCT07739901
- Acronym / sponsor ID
- NN9931-8923
- Conditions
- MASLD/MASH
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort with MASLD/MASH | – | Other: No treatment is givenAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment is givenThis is a retrospective observational cohort study. The data will be collected via EMR. | Other | cohort with MASLD/MASH |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for MASLD/MASH
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASLD/MASH, run by Novo Nordisk A/S at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.