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

NCT06741111 | Completed

• 2 other identifiers: DAS-8256U1111-1308-1064
• Study Type: observational
• Target: 1,233,970
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  January 1st, 2023, to December 31st, 2023

Study Arms (1)

Cohort

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

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• For EASL not at-risk population
• \. 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.

You may not qualify if:

• 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
• 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
• \. Missing value on globulin

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bangalore, India

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: January 21, 2025
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)