Real-world identification, staging, monitoring, management, and progression in patients with metabolic dysfunction-associated steatohepatitis (MASH) across the fibrosis spectrum in EU4+UK: A retrospective multi-country chart review on compensated MASH cirrhosis (MASH-MAP)

20/10/2026
26/10/2026
EU PAS number:
EUPAS1000001142
Study
Planned
Study identification

EU PAS number

EUPAS1000001142

Study ID

1000001142

Official title and acronym

Real-world identification, staging, monitoring, management, and progression in patients with metabolic dysfunction-associated steatohepatitis (MASH) across the fibrosis spectrum in EU4+UK: A retrospective multi-country chart review on compensated MASH cirrhosis (MASH-MAP)

DARWIN EU® study

No

Study countries

France
Germany
Italy
Spain
United Kingdom

Study description

Metabolic dysfunction-associated steatohepatitis (MASH) is a long-term liver disease linked to metabolic conditions such as obesity and diabetes. It can cause inflammation and increasing liver scarring (fibrosis), which may eventually lead to cirrhosis, liver failure, liver cancer, or death. However, there is limited information on how people with MASH are identified, assessed, monitored, and treated in everyday clinical practice, particularly those with cirrhosis who have not yet developed serious complications.

This study will review existing medical records from approximately 750 adults with MASH receiving care across approximately 60 hospitals and clinics that provide specialist care for liver disease in Germany, the United Kingdom, France, Italy, and Spain. No new treatments, tests, or study visits will be given as part of the research.

The study will examine how physicians diagnose MASH and determine the amount of liver scarring (fibrosis staging) using blood-based tests, scans, liver biopsy, and other clinical information. It will also describe how patients are monitored and treated, how care differs according to the severity of liver scarring, and how often patients progress to more advanced disease. Particular attention will be given to patients with cirrhosis who have not yet developed complications.

The study will also explore whether information routinely recorded in medical records, such as diagnoses, procedures, medicines, and healthcare use, could help to identify patients with MASH-related cirrhosis in future research databases.

The findings are expected to improve understanding of how MASH is managed in routine European clinical practice and where there may be opportunities to improve disease identification, monitoring, and care.

Study status

Planned
Research institutions and networks

Institutions

GIPAM GmbH
Germany
United Kingdom
United States
First published:
10/10/2024
Institution Other ENCePP partner

Contact details

Thomas Wilke 0000-0001-8932-6426

Primary lead investigator
ORCID number:
0000-0001-8932-6426

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This study is funded by Madrigal Pharmaceuticals, Inc., the study sponsor.
Funding covers research activities undertaken by the research team and participating study sites, including project management, investigator and research staff time, local identification of eligible patients and abstraction of relevant information from medical charts, data management, statistical analysis, and administrative costs associated with study conduct.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable