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Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT02854605
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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 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


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




Primary Outcome Measures :
  1. Overall Safety of GS-9674 as Assessed By Proportion of Participants Experiencing Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to 24 weeks plus 30 days ]
  2. Overall Safety of GS-9674 as Assessed By Proportion of Participants with Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days ]


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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.


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


  Show 37 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02854605     History of Changes
Other Study ID Numbers: GS-US-402-1852
2016-002496-10 ( EudraCT Number )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases