SEL, GS-0976, GS-9674 in NASH

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens (SEL, GS-0976, GS-9674, or the Combination of SEL and GS-9674), in Subjects With NASH (GS-US-384-3914)

Eligibility

Key Inclusion Criteria

  • 18-75 years old
  • Groups 1-6:
    • Diagnosis of nonalcoholic fatty liver disease
    • Screening FibroTest <0.75
    • Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% steatosis
    • Screening magnetic resonance elastography (MRE) with liver stiffness ≥2.88 kPa, or
    • Historical liver biopsy consistent with NASH with stage 2-3 fibrosis, and
    • No documented weight loss >5% between the date of the liver biopsy and screening

Key Exclusion Criteria

  • Pregnant or lactating
  • Other causes of liver disease including autoimmune, viral and alcoholic liver disease
  • History of decompensated liver disease

Full Study Name

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH) (IRB no. 48332)

Summary

The purpose of this study is to evaluate the experimental drugs selonsertib (SEL; formerly GS-4997), GS-0976 and GS-9674 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a disease that results when fat accumulates in the liver. The body’s immune system may respond to the fat by attacking liver cells and over time, scar tissue (fibrosis) forms. SEL, GS-0976 and GS-9674 are intended to reduce inflammation, fibrosis, and fat buildup in the liver. Researchers will assess the safety, tolerability and effectiveness of these drugs in NASH patients.

Phase

Phase II


Principal Investigator

Mazen Noureddin, MD

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