Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- Drug: Placebo to match GS-9674
- Registration Number
- NCT02854605
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
-
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)
Key
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GS-9674 30 mg Placebo to match GS-9674 GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks GS-9674 30 mg GS-9674 GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks GS-9674 100 mg GS-9674 GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks GS-9674 100 mg Placebo to match GS-9674 GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks Placebo Placebo to match GS-9674 Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
- Primary Outcome Measures
Name Time Method Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Toronto Liver Center
🇨🇦Toronto, Ontario, Canada
LMC Clinical Research Inc (Bayview)
🇨🇦Toronto, Ontario, Canada
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Duke University Medical Center, Duke South Clinics
🇺🇸Durham, North Carolina, United States
Pinnacle Clinical Research
🇺🇸Live Oak, Texas, United States
Concorde Medical Group, PLLC
🇺🇸New York, New York, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System
🇺🇸Durham, North Carolina, United States
Texas Digestive Disease Consultants
🇺🇸Dallas, Texas, United States
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Intermountain Liver Disease and Transplant Center
🇺🇸Murray, Utah, United States
Toronto Digestive Disease Associates, Inc.
🇨🇦Vaughan, Ontario, Canada
Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
🇨🇭Bern, Switzerland
Ruane Clinical Research Group Inc.
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital, Clinical Research Unit
🇺🇸Chicago, Illinois, United States
Crescent Clinical Research Center, LLC
🇺🇸Metairie, Louisiana, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
🇺🇸Newport News, Virginia, United States
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
Auckland Clinical Studies
🇳🇿Auckland, New Zealand
Quality Medical Research, PC
🇺🇸Nashville, Tennessee, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
University of Calgary
🇨🇦Calgary, Alberta, Canada
The Chinese University of Hong Kong
🇭🇰Sha Tin, Hong Kong
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Princess Margaret Hospital
🇭🇰Kowloon, Hong Kong