NCT03987074 trial results

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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) Note: Other protocol defined Inclusion/Exclusion criteria may apply.