Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated 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)

Keywords

Nonalcoholic Steatohepatitis, Fatty Liver, Non-alcoholic Fatty Liver Disease, 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

Eligibility

You can join if…

Open to people ages 18-80

  • Liver biopsy consistent with cirrhosis (F4) due to NASH in the opinion of the central reader. In participants 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%
  • 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
  • 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 HBV infection (HBsAg positive), or Chronic HCV infection (HCV antibody and HCV RNA positive). Participants 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 (one unit is equivalent to 12 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 participants who have not completed a series of an authorized COVID-19 vaccination regimen prior to screening, a positive result for COVID-19 on SARS-CoV-2 RT-PCR test

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

Locations

  • University of California, San Francisco - Liver Clinic accepting new patients
    San Francisco California 94143 United States
  • Quest Clinical Research accepting new patients
    San Francisco California 94115 United States
  • Stanford Medicine Outpatient Center accepting new patients
    Redwood City California 94063 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT04971785
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 440 study participants
Last Updated