Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Trial end date: 2020-07-13
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Novo Nordisk A/S
• Treatments: Firsocostat

Criteria

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.