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OpenTrials
Completed

NCT Number: NCT06741111

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Bangalore, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • Liver steatosis on abdominal ultrasound
  • With at least one component of Metabolic syndrome (MetS [CSH])

Exclusion criteria

  • 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

Treatment and study plan

No treatment given

Other

No treatment given

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.

    Time frame: January 1st, 2023, to December 31st, 2023

    Number and proportion of people in respective risk population

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: IMPACT MASH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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