Global Research Initiative for Patients Screening on MASH

Inclusion Criteria:

• Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetesmellitus or metabolic syndrome or obesity or arterial hypertension, following thestudy definitions.

• Subjects that are currently being treated for type 2 diabetes mellitus or metabolicsyndrome or obesity or arterial hypertension, should have had a prior diagnosisbased 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 careprovider

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 healthcare 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 lipidabnormality

• 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, ortreatment of previously diagnosed hypertension

• Raised fasting plasma glucose (FPG): FGP ≥ 100 mg/dL (5.6 mmol/L), or previouslydiagnosed type 2 diabetes (if above >5.6 mmol/L or 100 mg/dL, an oral glucosetolerance test is strongly recommended, but is not necessary to define presence ofthe syndrome)

Exclusion Criteria:

• The patient is known with hepatitis B, C or HIV or any other liver condition (likehemochromatosis, sarcoidosis, Wilson's disease etc);

• The patient is known with any other condition that may lead to liver fibrosis orcirrhosis;

• The patient engages in (excessive) alcohol use: > 3 units/day in males [30grams/day] and > 2 units/day in females [20 grams/day];

• The patient has a history or evidence of any other clinically significant conditionor planned or expected procedure that in the opinion of the Investigator, maycompromise 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 thestudy or is a family member of the Investigator, sub-Investigator, or any Sponsorpersonnel;

• The patient is not able to understand the details of the protocol and/or is not ableto provide written informed consent;

• The patient is pregnant or breastfeeding.

• The patient underwent bariatric surgery in the last 12 months.