Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)IMPACT MASHNCT06741111
A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
An observational study of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), run by Novo Nordisk A/S at 1 site in India.
Trial summary
The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)
- What is being tested?
- No treatment given
- How many people
- 1,233,970 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jan 2025to 27 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People who underwent health check-up in Meinian check-up centres between January 1st, 2023 to December 31st, 2023 and met the eligibility criteria.
Who may be able to join
- For All and Study population:
- Male or female, age above or equal to 18 years on health-check-up visit day
- No missing value on sex
- For EASL at risk population
- Must be part of study population.
- People with T2D or [obesity＋above or equal to 1 cardiometabolic risk factor(s)] or elevated liver enzymes
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- For EASL not at-risk population
- 1. Must be part of study population.
- For EASL-SAFE
- Must be part of EASL at risk population
- For AGA at risk population
- Must be part of study population.
- People with 2 or more metabolic risk factors (EASL-MASLD criteria) or T2D or steatosis on any imaging modality or with elevated aminotransferases
- For CSH MAFLD population
- Must be part of study population.
- Liver steatosis on abdominal ultrasound
- With at least one component of Metabolic syndrome (MetS [CSH])
Who cannot join
- Individuals originating from centers with fewer than 100 participants
- Missing value of liver stiffness measurement (LSM)
- Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
- Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
- Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
- Missing value on abdominal ultrasound
Show all 9Show fewer
- For EASL not at-risk population 1. People with T2D or [obesity＋above or equal to 1 cardiometabolic risk factor(s)] or elevated liver enzymes
- For EASL-SAFE/NFS
- 1. Missing value on globulin
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway
- Being tested
- No treatment given
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Cohort | People who underwent health check-up in Meinian check-up centres between the period January 1st, 2023, to December 31st, 2023 Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.
Number and proportion of people in respective risk population
Measured: January 1st, 2023, to December 31st, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start21 Jan 2025
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)Studies 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
- 1,233,970 participants (actual)
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
- NCT06741111
- Sponsor's protocol ID
- DAS-8256
- Other IDs
- U1111-1308-1064
- Acronym
- IMPACT MASH
- Status last verified
- Jun 2025
- First submitted
- 16 Dec 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
- ClinicalTrials.gov ID
- NCT06741111
- Acronym / sponsor ID
- IMPACT MASH / DAS-8256
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,233,970 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 18 Dec 2024 (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.
The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL) 2024 care pathway
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: No treatment givenPeople who underwent health check-up in Meinian check-up centres between the period January 1st, 2023, to December 31st, 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who underwent health check-up in Meinian check-up centres between January 1st, 2023 to December 31st, 2023 and met the eligibility criteria.
Key inclusion criteria (17 listed)
- Male or female, age above or equal to 18 years on health-check-up visit day
- No missing value on sex
- For EASL at risk population
- Must be part of study population.
- People with T2D or [obesity＋above or equal to 1 cardiometabolic risk factor(s)] or elevated liver enzymes
Key exclusion criteria (9 listed)
- Individuals originating from centers with fewer than 100 participants
- Missing value of liver stiffness measurement (LSM)
- Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
- Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
- Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
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 givenNo treatment given | Other | Cohort |
Primary outcome
The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway.
Time frame: January 1st, 2023, to December 31st, 2023
Number and proportion of people in respective risk population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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 Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH), run by Novo Nordisk A/S at 1 site in India.
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 17 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jun 2025. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of people with low/intermediate/high risk of advanced fibrosis in EASL at risk population based on EASL 2024 care pathway. (time frame: January 1st, 2023, to December 31st, 2023). 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 22 Jun 2025.