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

June 19, 2025 updated by: Novo Nordisk A/S
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1233970

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
January 1st, 2023, to December 31st, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Actual)

May 27, 2025

Study Completion (Actual)

May 27, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-8256
  • U1111-1308-1064 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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