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Eligibility
for people ages 18–75
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in adults with nonalcoholic steatohepatitis (NASH).

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Steatohepatitis (NASH)

Eligibility

For people ages 18–75

Key Inclusion Criteria:

  • Meets all of the following conditions:
  • A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
  • Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)with ≥ 8% steatosis
  • Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa
  • OR
  • A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
  • Platelet count ≥ 100,000/mm^3
  • Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min

Key Exclusion Criteria:

  • Pregnant or lactating females
  • Alanine aminotransferase (ALT)> 5 x upper limit of the normal range (ULN)
  • Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
  • Cirrhosis of the liver
  • Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
  • Body mass index (BMI) < 18 kg/m^2
  • International normalized ratio (INR)> 1.2 unless on anticoagulant therapy
  • Total bilirubin> 1 x ULN, except with diagnosis of Gilbert's syndrome

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

Locations

  • San Francisco, California, 94115, United States
  • Foster City, California, 94404, United States
  • Los Angeles, California, 90048, United States
  • Los Angeles, California, 90036, United States
  • Rialto, California, 92377, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02856555
Phase
Phase 2
Study Type
Interventional
Last Updated
April 1, 2017