for people ages 18-75 (full criteria)
study started
estimated completion



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

Official Title

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)


Nonalcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease Firsocostat Semaglutide Cilofexor Semaglutide + Firsocostat Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat + Cilofexor


For people ages 18-75

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/m2 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.


  • University of California San Diego (UCSD)
    La Jolla California 92037 United States
  • Cedars Sinai Medical Center
    Los Angeles California 90048 United States
  • Ruane Clinical Research Group, Inc
    Los Angeles California 90036 United States
  • Medical Associates Research Group
    San Diego California 92123 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 2
Study Type
Last Updated