A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database

NCT ID: NCT06741111

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1233970 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-21

Study Completion Date

2025-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

People who underwent health check-up in Meinian check-up centres between the period January 1st, 2023, to December 31st, 2023

No treatment given

Intervention Type OTHER

No treatment given

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No treatment given

No treatment given

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

For All and Study population:

1. Male or female, age above or equal to 18 years on health-check-up visit day
2. No missing value on sex

For EASL at risk population

1. Must be part of study population.
2. People with T2D or \[obesity+above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes

For EASL not at-risk population

1\. Must be part of study population.

For EASL-SAFE

1. Must be part of EASL at risk population

For AGA at risk population

1. Must be part of study population.
2. 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

1. Must be part of study population.
2. Liver steatosis on abdominal ultrasound
3. With at least one component of Metabolic syndrome (MetS \[CSH\])

Exclusion Criteria

1. Individuals originating from centers with fewer than 100 participants
2. Missing value of liver stiffness measurement (LSM)
3. Had an interquartile range/median ratio above or equal to 30% of the measurement of LSM
4. Missing value on either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or platelet count (PLT)
5. Missing value on FPG, TG, HDLc or BP (to define the presence of metabolic risk factors)
6. Missing value on abdominal ultrasound

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1308-1064

Identifier Type: OTHER

Identifier Source: secondary_id

DAS-8256

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase 2b Study of GSK4532990 in Adults With NASH
NCT05583344 ACTIVE_NOT_RECRUITING PHASE2