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Screening patients at risk for liver disease in Europe

Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway

Observational Julius Clinical · NCT05651724

This study is trying to find out if screening high-risk patients in Europe for liver disease using simple tests can help doctors identify and better understand conditions like metabolic dysfunction-associated steatotic liver disease.

Quick facts

Study typeObservational
Enrollment10000 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorJulius Clinical Industry-sponsored
Locations13 sites (Brussels, Vlaams-brabant and 12 other locations)
Trial IDNCT05651724 on ClinicalTrials.gov

What this trial studies

The GRIPonMASH initiative aims to assist primary healthcare providers in implementing a patient care pathway to identify individuals at risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH). This observational study will screen 10,000 high-risk patients across 10 European countries using non-invasive tests such as FIB-4 and FibroScan, alongside blood samples and liver biopsies for further analysis. The study will also explore genomic and metabolic markers to enhance understanding of MASLD and improve patient identification. Participants will be followed for five years to observe the disease's natural progression.

Who should consider this trial

Good fit: Ideal candidates include individuals newly diagnosed with type 2 diabetes, metabolic syndrome, obesity, or arterial hypertension.

Not a fit: Patients without any of the specified conditions or those not at risk for MASLD will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could lead to earlier detection and better management of liver diseases, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using non-invasive tests for liver disease screening, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.
* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.

Study definitions:

Type 2 diabetes mellitus

* At least 2 times a fasting glucose \> 7,0 mmol/L
* Or elevated non-fasting glucose \>11,1 mmol/L 2 hrs after OGTT
* Or HbA1c ≥48 mmol/mol (≥6.5%)
* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider

Obesity

* Body mass index (BMI) \> 30
* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian/Chinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm

Arterial hypertension

* Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
* Or being actively treated for previously diagnosed arterial hypertension by a health care provider

Metabolic syndrome

\- Central obesity defined as waist circumference (see above), if BMI is \>30 kg/m2, central obesity can be assumed and waist circumference does not need to be measured

AND any two of the following:

* Raised triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality
* Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in males, \< 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality
* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension
* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (if above \>5.6 mmol/L or 100 mg/dL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)

Exclusion Criteria:

* The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);
* The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;
* The patient engages in (excessive) alcohol use: \> 3 units/day in males \[30 grams/day\] and \> 2 units/day in females \[20 grams/day\];
* The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;
* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;
* The patient is not able to understand the details of the protocol and/or is not able to provide written informed consent;
* The patient is pregnant or breastfeeding.
* The patient underwent bariatric surgery in the last 12 months.

Where this trial is running

Brussels, Vlaams-brabant and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MASHMASLDMASH With FibrosisFibrosis, LiverSteatosis of LiverType 2 DiabetesObesityMetabolic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.