Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
NCT ID: NCT02856555
Last Updated: 2020-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2016-08-08
2017-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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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.
Firsocostat
Capsules orally once daily.
Placebo
Placebo matched to firsocostat orally once daily.
Firsocostat 20 mg
Participants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
Firsocostat
Capsules orally once daily.
Placebo
Placebo matched to firsocostat orally once daily.
Placebo
Participants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Placebo
Placebo matched to firsocostat orally once daily.
Interventions
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Firsocostat
Capsules orally once daily.
Placebo
Placebo matched to firsocostat orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Coronado, California, United States
Foster City, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Rialto, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
Miami, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
New York, New York, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Live Oak, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Falls Church, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richland, Washington, United States
Seattle, Washington, United States
Countries
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References
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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.
Loomba R, Kayali Z, Noureddin M, Ruane P, Lawitz EJ, Bennett M, Wang L, Harting E, Tarrant JM, McColgan BJ, Chung C, Ray AS, Subramanian GM, Myers RP, Middleton MS, Lai M, Charlton M, Harrison SA. GS-0976 Reduces Hepatic Steatosis and Fibrosis Markers in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2018 Nov;155(5):1463-1473.e6. doi: 10.1053/j.gastro.2018.07.027. Epub 2018 Jul 27.
Lawitz EJ, Coste A, Poordad F, Alkhouri N, Loo N, McColgan BJ, Tarrant JM, Nguyen T, Han L, Chung C, Ray AS, McHutchison JG, Subramanian GM, Myers RP, Middleton MS, Sirlin C, Loomba R, Nyangau E, Fitch M, Li K, Hellerstein M. Acetyl-CoA Carboxylase Inhibitor GS-0976 for 12 Weeks Reduces Hepatic De Novo Lipogenesis and Steatosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1983-1991.e3. doi: 10.1016/j.cgh.2018.04.042. Epub 2018 Apr 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-426-3989
Identifier Type: -
Identifier Source: org_study_id
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