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GS-0976 in Adults With Nonalcoholic Steatohepatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02856555
First Posted: August 5, 2016
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
August 2, 2016
August 5, 2016
August 4, 2017
August 8, 2016
July 18, 2017   (Final data collection date for primary outcome measure)
Overall Safety Profile of GS-0976 assessed as the percentage of participants experiencing treatment-emergent adverse events [ Time Frame: Up to 12 weeks plus 30 days ]
The overall safety profile of GS-0976 will be assessed as the percentage of participants experiencing treatment-emergent adverse events (TEAE), serious TEAEs, TEAEs leading to premature study drug discontinuation, and treatment-emergent clinically significant laboratory abnormalities.
Same as current
Complete list of historical versions of study NCT02856555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
GS-0976 in Adults With Nonalcoholic Steatohepatitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate the safety and tolerability of GS-0976 in adults with nonalcoholic steatohepatitis (NASH).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Nonalcoholic Steatohepatitis (NASH)
  • Drug: GS-0976
    Capsule(s) administered orally once daily
  • Drug: Placebo
    Capsule(s) administered orally once daily
  • Experimental: GS-0976 5 mg
    GS-0976 5 mg + placebo for 12 weeks
    Interventions:
    • Drug: GS-0976
    • Drug: Placebo
  • Experimental: GS-0976 20 mg
    GS-0976 20 mg + placebo for 12 weeks
    Interventions:
    • Drug: GS-0976
    • Drug: Placebo
  • Experimental: Placebo
    Placebo for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
July 18, 2017
July 18, 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02856555
GS-US-426-3989
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP