Overview

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.