Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
With
Novo Nordisk A/S
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan
Screening laboratory parameters, as determined by central laboratory:
* Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)
* Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation
* HbA1c ≤ 9.5%
* International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy
* Platelet count ≥ 100,000/μL
* Total bilirubin \< 1.3 x ULN unless alternate etiology such as Gilbert's syndrome present
* Calcitonin ≤ 100 ng/L
Body Mass Index (BMI) \> 23 kg/m\^2 and body weight of \> 60 kg
You may not be if
Any historical liver biopsy consistent with cirrhosis
Any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
Other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
History of liver transplantation
History of hepatocellular carcinoma
History of pancreatitis (acute or chronic)
Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA) in the period from 90 days prior to the date of the Screening Visit
Individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the Screening Visit and in the period between the date of the Screening Visit and Enrollment (Day -14)
