A Multi-country, Cross-sectional Quantitative Study Exploring Awareness, Understanding, and Perceptions of the Relation Between Cardiorenal Metabolic Conditions and MASLD/MASH Among Healthcare Providers, People With MASLD/MASH, and At-risk Population

Novo Nordisk

Status: Invitation-only

Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT07201831

U1111-1308-2796 (Other Identifier)

DAS-8185

Details and patient eligibility

About

The purpose of this study is to collect information for scientific research and to better understand awareness and to understand overall risk awareness, diagnoses and treatment related to liver related diseases. The study aims to collect valid responses through online questionnaires from the participants. This study is a survey-based study without collection of laboratory data. It will take the participant 25 minutes to complete the survey. The study is not related to any specific treatment options or pharmaceutical product.

Enrollment: 1,320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HCP inclusion criteria

• Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• Licensed to practice medicine in one of the countries of interest: United States, Canada, France, Germany, Japan
• Must be a practicing endocrinologist, hepatologist, cardiologist, obesity specialist, primary care physician, radiologist, nurse practitioner or physician assistant (NP/PA US only)
• Must be at least "somewhat familiar" (as opposed to "not at all familiar) with Metabolic dysfunction-associated steatohepatitis (MASH) (do not need to be currently treating people with MASH) 6. Must have at least 2 years in practice 7. Must spend at least 50 percentage of their time in patient care

Diagnosed patient inclusion criteria

• Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• Diagnosis of MASH or Metabolic Associated Steatotic Liver Disease (MASLD) within past 24 months
• Live in one of the countries of interest: United States, Canada, France, Germany, Japan
• Have at least one comorbid condition: obesity, pre-diabetes, type 2 diabetes (T2D), metabolic syndrome, dyslipidaemia, hypertension, cardiovascular disease, chronic kidney disease

At risk patient inclusion criteria

• Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• Male or female, age above or equal to 18 years at the time of signing informed consent.
• Live in one of the countries of interest: United States, Canada, France, Germany, Japan
• Must have one or more risk factors associated with MASH [obesity, pre-diabetes, type 2 diabetes (T2D), metabolic syndrome, dyslipidaemia, hypertension, cardiovascular disease, chronic kidney disease], be diagnosed with steatosis (incidental finding) or have a blood test that shows raised liver enzymes.

Exclusion criteria

• Previous participation in this study. Participation is defined as having given informed consent in this study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial design

1,320 participants in 2 patient groups

HCP Group

Description:

This group includes Health Care Practitioners (HCPs) who self-report to being at least somewhat familiar with Metabolic dysfunction-associated steatohepatitis (MASH)

Treatment:

Other: No treatment given

Patient Groups

Description:

This group includes patients diagnosed with Metabolic dysfunction-associated steatohepatitis (MASH), diagnosed with Metabolic Associated Steatotic Liver Disease (MASLD), or at risk for development/diagnosis of MASH

Treatment:

Other: No treatment given