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Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

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ClinicalTrials.gov Identifier: NCT02466516
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study will evaluate the safety and tolerability of GS-4997 alone or in combination with Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis (NASH) Drug: GS-4997 Biological: SIM Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: GS-4997 6 mg
GS-4997 6 mg for 24 weeks
Drug: GS-4997
GS-4997 tablets administered orally once daily

Experimental: GS-4997 18 mg
GS-4997 18 mg for 24 weeks
Drug: GS-4997
GS-4997 tablets administered orally once daily

Experimental: GS-4997 6 mg+SIM 125 mg
GS-4997 6 mg plus SIM 125 mg for 24 weeks
Drug: GS-4997
GS-4997 tablets administered orally once daily

Biological: SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Other Name: GS-6624

Experimental: GS-4997 18 mg+SIM 125 mg
GS-4997 18 mg plus SIM 125 mg for 24 weeks
Drug: GS-4997
GS-4997 tablets administered orally once daily

Biological: SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Other Name: GS-6624

Experimental: SIM 125 mg
SIM 125 mg for 24 weeks
Biological: SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Other Name: GS-6624




Primary Outcome Measures :
  1. Adverse event profile of GS-4997 [ Time Frame: Up to 28 weeks ]

    Reported adverse events will include:

    • Incidence of treatment-emergent serious adverse events
    • Incidence of worsening of treatment-emergent liver laboratory abnormalities for alanine aminotransferase (ALT) and aspartate aminotransferase (AST), defined as at least 1 toxicity grade increase from baseline

  2. Percentage of participants who prematurely discontinued study drug or study due to adverse events [ Time Frame: Up to 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Males and non-pregnant, non-lactating females
  • Evidence of NASH with fibrosis on biopsy

Key Exclusion Criteria:

  • Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)
  • Other causes of liver disease including viral hepatitis and alcoholic liver disease
  • Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
  • History of liver transplantation
  • Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol)

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): NCT02466516


  Show 28 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02466516     History of Changes
Other Study ID Numbers: GS-US-384-1497
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: November 2016

Keywords provided by Gilead Sciences:
GS-4997
Non-alcoholic fatty liver disease (NAFLD)
Fibrosis
Simtuzumab

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