Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Albireo
A total of 15 investigators at 15 sites received institutional review board (IRB)/ethics committee (EC) approval to participate in this study and enrolled at least 1 participant.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
Fasting serum low density lipoprotein-cholesterol (LDL-C) \>130 mg/dL at Screening, \>110 mg/dL on lipid-lowering medications
You may not be if
Body mass index (BMI) \<25 kg/m2
Fibrosis-4 index (Fib-4) \>2.6
Any of the following laboratory abnormalities:
1. alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) \>5 × ULN
2. International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
3. Total bilirubin \>ULN, except with an established diagnosis of Gilbert's syndrome
4. Platelet count less than the lower limit of normal (LLN)
5. Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation \<60 mL/min
Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) \>9.5%
Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
Uncontrolled hypertension
Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures
