Gilead-5533

Condition: Nonalcoholic steatohepatitis

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
  • Screening FibroTest <0.75; MRI-PDFF with ≥10% steatosis; FibroScan with liver stiffness ≥7 kPa

        OR

  • Historical liver biopsy within 6 months of screening consistent with NASH with stage 2-3 fibrosis

Key Exclusion Criteria

  • Documented weight loss >5% within 6 months of screening
  • Historical liver biopsy consistent with cirrhosis
  • Pregnant or lactating 

Full Study Name

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH) (IRB no. STUDY00000148)

Summary

This study focuses on patients with nonalcoholic steatohepatitis (NASH), a condition in which fat accumulates in the liver, and liver cells become injured. The purpose of the study is to evaluate the safety and tolerability of the experimental drugs semaglutide, firsocostat and cilofexor for the treatment of NASH. Semaglutide, firsocostat, cilofexor are intended to reduce inflammation and fibrosis (scarring) in the liver. Researchers aim to determine the effects of these drugs and their combinations in NASH patients.

The study will also assess whether a biomarker test may help monitor the patient’s response to the drug over time or help determine which individuals respond to the drug. A biomarker is a biological molecule found in blood, bodily fluids or tissues that may be a sign of a condition or disease.

Principal Investigator

Mazen Noureddin, MD

Contact