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Trial record 1 of 1 for:    NCT02854605
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Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

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.
 
ClinicalTrials.gov Identifier: NCT02854605
Recruitment Status : Completed
First Posted : August 3, 2016
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: GS-9674 Drug: Placebo to match GS-9674 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
 Drug: GS-9674
Tablet administered orally once daily

Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily
Experimental: GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
 Drug: GS-9674
Tablet administered orally once daily

Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily
Placebo Comparator: Placebo
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
 Drug: Placebo to match GS-9674
Tablet(s) administered orally once daily


Outcome Measures
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Primary Outcome Measures :
  1. Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 24 weeks plus 30 days ]
    TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.

  2. Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days ]
    Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Meets 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 kilopascal (kPa) OR
    • A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
    • No documented weight loss > 5% between the date of the liver biopsy and screening.
  • Platelet count ≥ 150,000/mm^3
  • Albumin ≥ 3.3 g/dL
  • Serum creatinine ≤ upper limit of normal (ULN)

Key Exclusion Criteria:

  • Pregnant or lactating females
  • Alanine aminotransferase (ALT) > 5x 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
  • Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854605


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] June 28, 2016
Study Protocol: Amendment 1  [PDF] October 3, 2016
Study Protocol: Amendment 2  [PDF] January 24, 2017
Statistical Analysis Plan  [PDF] September 6, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02854605    
Other Study ID Numbers: GS-US-402-1852
2016-002496-10 ( EudraCT Number )
First Posted: August 3, 2016    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Non-alcoholic fatty liver disease (NAFLD)
Fibrosis
GS-9674
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases