Clinical Trials

OVERVIEW

The Division of Gastroenterology and Hepatology conducts clinical trials on novel therapeutics for various liver diseases, bringing promising and innovative therapies to our patients.

Our team has extensive experience selecting the right patients for the right trials.

Clinical trials are an important part of the research involved in developing new medical treatments. Enrolling in a clinical trial enables participants to take an active role in their own health care, gain entrance to new research, and contribute to medical science.

Participants must meet specific criteria to be eligible for enrollment in a clinical trial. Some research studies seek participants with illnesses or specific conditions to be studied in the clinicaltrial, while others ask for healthy participants.

CURRENT AND ONGOING TRIALS

Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Semaglutide (SEMA)
  • drug: Cilofexor (CILO)/Firsocostat (FIR)
  • drug: PTM SEMA
  • drug: PTM CILO/FIR

Eligibility


Key Inclusion Criteria:

   - 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/1.73m^2, 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/m^2 at screening.

Key Exclusion Criteria:

   - 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.

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Smart
650-721-8517
Not Recruiting