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Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis

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: NCT02856555
Recruitment Status : Completed
First Posted : August 5, 2016
Results First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Sequential 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: Firsocostat 5 mg
Participants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Drug: Firsocostat
Capsules orally once daily.
Other Name: GS-0976

Drug: Placebo
Placebo matched to firsocostat orally once daily.

Experimental: Firsocostat 20 mg
Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
Drug: Firsocostat
Capsules orally once daily.
Other Name: GS-0976

Drug: Placebo
Placebo matched to firsocostat orally once daily.

Experimental: Placebo
Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Drug: Placebo
Placebo matched to firsocostat orally once daily.




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: First Dose date up to last dose (Week 12) plus 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, California
Coronado, California, United States, 92118
Foster City, California, United States, 94404
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90048
Rialto, California, United States, 92377
San Diego, California, United States, 92103
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143
United States, Florida
Miami, Florida, United States, 33136
Miami, Florida, United States, 33165
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, New York
New York, New York, United States, 10016
United States, North Carolina
Durham, North Carolina, United States, 27710
Statesville, North Carolina, United States, 28677
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19707
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Germantown, Tennessee, United States, 38138
Memphis, Tennessee, United States, 38104
Nashville, Tennessee, United States, 37211
United States, Texas
Arlington, Texas, United States, 76012
Live Oak, Texas, United States, 78233
San Antonio, Texas, United States, 78215
United States, Utah
Murray, Utah, United States, 84107
United States, Virginia
Falls Church, Virginia, United States, 22042
Richmond, Virginia, United States, 23226
Richmond, Virginia, United States, 23249
Richmond, Virginia, United States, 23298
United States, Washington
Richland, Washington, United States, 99352
Seattle, Washington, United States, 98104
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  [PDF] December 15, 2016
Statistical Analysis Plan  [PDF] July 21, 2017

Publications of Results:
Loomba R, Kayali Z, Noureddin M, Ruane P, Lawitz EJ, Gitlin N, Bennett M, Harting EJ, McColgan BJ, Myers RP, Subramanian GM, McHutchison JG, Middleton MS, Sirlin C, Lai M, Charlton M, Harrison SA. Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 leads to significant improvements in MRI-PDFF in a Phase 2, randomized, placebo-controlled trial of patients with NASH. American Association for the Study of Liver Diseases Meeting; 2017; Washington, DC, USA.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02856555    
Other Study ID Numbers: GS-US-426-3989
First Posted: August 5, 2016    Key Record Dates
Results First Posted: July 24, 2020
Last Update Posted: July 24, 2020
Last Verified: July 2020

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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
Firsocostat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action