for people ages 18-80 (full criteria)
study started
completion around



The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.

Official Title

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)


Nonalcoholic Steatohepatitis, Fatty Liver, Non-alcoholic Fatty Liver Disease, Semaglutide, Firsocostat, Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR, SEMA + CILO/FIR FDC, PTM SEMA + CILO/FIR FDC, PTM SEMA + PTM CILO/FIR


You can join if…

Open to people ages 18-80

  • Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed.
  • Screening laboratory parameters as determined by the study central laboratory:
    • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2, as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
    • HbA1c ≤ 10%
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
    • Platelet count ≥ 125,000/uL
    • Alanine aminotransferase (ALT) < 5 x ULN
    • Serum albumin ≥ 3.5 g/dL
    • Serum alkaline phosphatase (ALP) ≤ 2 x ULN
  • Body mass index (BMI) ≥ 23 kg/m2 at screening.

You CAN'T join if...

  • Prior history of decompensated liver disease, including ascites, hepatic encephalopathy (HE), or variceal bleeding.
  • Child-Pugh (CP) score > 6 at screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation.
  • Model for End-stage Liver Disease (MELD) score > 12 at screening, unless due to an alternative etiology such as therapeutic anticoagulation.
  • Other causes of liver disease based on medical history and/or central reader review of liver histology, including but not limited to: alcoholic liver disease, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.
  • Chronic hepatitis B virus (HBV) infection (HBsAg positive), or Chronic hepatitis C virus (HCV) infection (HCV antibody and HCV ribonucleic acid (RNA) positive). Individuals cured of HCV infection less than 2 years prior to the screening visit are not eligible.
  • History of liver transplantation.
  • Current or prior history of hepatocellular carcinoma (HCC).
  • Men who habitually drink greater than 21 units/week of alcohol or women who habitually drink greater than 14 units/week of alcohol (1 unit is equivalent to 12 ounce (oz)/360 mL of beer, a 4 oz/120 mL glass of wine, or 1 oz/30 mL of hard liquor).
    • For individuals on vitamin E regimen ≥ 800 IU/day, or pioglitazone, dose must be stable, in the opinion of the investigator for at least 180 days prior to the historical or screening liver biopsy.
    • For individuals on medications for diabetes, dose must be stable, in the opinion of the investigator, for at least 90 days prior to the historical or screening liver biopsy.
  • History of type 1 diabetes.
  • Treatment with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the period from 90 days prior to the screening visit and for individuals with a qualifying historical liver biopsy, for 90 days prior to the date of the historical liver biopsy.
  • For individuals who have not completed a series of an authorized coronavirus disease 2019 (COVID-19) vaccination regimen prior to screening, a positive result for COVID-19 on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase-polymerase chain reaction (RT-PCR) test.

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.


  • University of California, San Francisco - Fresno
    Fresno California 93701 United States
  • University of California, San Diego - Altman Clinical and Translational Research Institute
    La Jolla California 92037 United States
  • University of California, Davis Medical Center
    Sacramento California 95817 United States
  • University of California, San Francisco - Liver Clinic
    San Francisco California 94143 United States
  • Quest Clinical Research
    San Francisco California 94115 United States
  • Biopharma Informatic, LLC
    Los Angeles California 90035 United States
  • Medical Associates Research Group
    San Diego California 92123 United States
  • TriWest Research Associates, LLC
    San Diego California 92108 United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles California 90027 United States
  • Knowledge Research Center
    Orange California 92868 United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Gilead Clinical Trials Website
Phase 2 research study
Study Type
About 457 people participating
Last Updated