Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
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ClinicalTrials.gov Identifier: NCT02856555 |
Recruitment Status :
Completed
First Posted : August 5, 2016
Results First Posted : July 24, 2020
Last Update Posted : July 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nonalcoholic Steatohepatitis (NASH) | Drug: Firsocostat Drug: Placebo | Phase 2 |
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. |
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: First Dose date up to last dose (Week 12) 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 |
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.

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
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 |
Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |
Firsocostat Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |