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GS-0976 in Adults With Nonalcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT02856555
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : July 11, 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-0976 in adults with nonalcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: GS-0976 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 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-0976 in Subjects With Nonalcoholic Steatohepatitis
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : July 18, 2017
Actual Study Completion Date : July 18, 2017


Arm Intervention/treatment
Experimental: GS-0976 5 mg
GS-0976 5 mg + placebo for 12 weeks
Drug: GS-0976
Capsule(s) administered orally once daily

Drug: Placebo
Capsule(s) administered orally once daily

Experimental: GS-0976 20 mg
GS-0976 20 mg + placebo for 12 weeks
Drug: GS-0976
Capsule(s) administered orally once daily

Drug: Placebo
Capsule(s) administered orally once daily

Experimental: Placebo
Placebo for 12 weeks
Drug: Placebo
Capsule(s) administered orally once daily




Primary Outcome Measures :
  1. 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.



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 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.


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): NCT02856555


  Show 36 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02856555     History of Changes
Other Study ID Numbers: GS-US-426-3989
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases