A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Overview
- Phase
- Phase 2
- Intervention
- GS-9674
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Sponsor
- Gilead Sciences
- Enrollment
- 140
- Locations
- 37
- Primary Endpoint
- Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meets 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 kilopascal (kPa) OR
- •A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
- •No documented weight loss \> 5% between the date of the liver biopsy and screening.
- •Platelet count ≥ 150,000/mm\^3
- •Albumin ≥ 3.3 g/dL
- •Serum creatinine ≤ upper limit of normal (ULN)
Exclusion Criteria
- •Pregnant or lactating females
- •Alanine aminotransferase (ALT) \> 5x 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
- •Uncontrolled diabetes mellitus (hemoglobin A1c \> 9% at screening)
- •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.
Arms & Interventions
GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Intervention: GS-9674
GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Intervention: Placebo to match GS-9674
GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
Intervention: GS-9674
GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
Intervention: Placebo to match GS-9674
Placebo
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Intervention: Placebo to match GS-9674
Outcomes
Primary Outcomes
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 24 weeks plus 30 days
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Time Frame: Up to 24 weeks plus 30 days
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.