Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
2 other identifiers
interventional
140
6 countries
37
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2016
Shorter than P25 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedStudy Start
First participant enrolled
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2018
CompletedResults Posted
Study results publicly available
January 29, 2019
CompletedJanuary 29, 2019
January 1, 2019
1.2 years
July 29, 2016
January 7, 2019
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
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.
Up to 24 weeks plus 30 days
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
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.
Up to 24 weeks plus 30 days
Study Arms (3)
GS-9674 30 mg
EXPERIMENTALGS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
GS-9674 100 mg
EXPERIMENTALGS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
Placebo
PLACEBO COMPARATORPlacebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Interventions
Tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (37)
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308, United States
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, 60611, United States
Crescent Clinical Research Center, LLC
Metairie, Louisiana, 70006, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Concorde Medical Group, PLLC
New York, New York, 10016, United States
Duke University Medical Center, Duke South Clinics
Durham, North Carolina, 27710, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System
Durham, North Carolina, 28078, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research, PC
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Pinnacle Clinical Research
Live Oak, Texas, 78233, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
Intermountain Liver Disease and Transplant Center
Murray, Utah, 84107, United States
Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
LMC Clinical Research Inc (Bayview)
Toronto, Ontario, M4G 3E8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Liver Center
Toronto, Ontario, M6H 3M1, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Princess Margaret Hospital
Kowloon, Hong Kong
The Chinese University of Hong Kong
Shatin, Hong Kong
Auckland Clinical Studies
Auckland, 1010, New Zealand
Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
Bern, 3010, Switzerland
Universitatsspital Zurich
Zurich, CH-8091, Switzerland
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Related Publications (1)
Patel K, Harrison SA, Elkhashab M, Trotter JF, Herring R, Rojter SE, Kayali Z, Wong VW, Greenbloom S, Jayakumar S, Shiffman ML, Freilich B, Lawitz EJ, Gane EJ, Harting E, Xu J, Billin AN, Chung C, Djedjos CS, Subramanian GM, Myers RP, Middleton MS, Rinella M, Noureddin M. Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. Hepatology. 2020 Jul;72(1):58-71. doi: 10.1002/hep.31205.
PMID: 32115759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 3, 2016
Study Start
October 26, 2016
Primary Completion
January 9, 2018
Study Completion
January 9, 2018
Last Updated
January 29, 2019
Results First Posted
January 29, 2019
Record last verified: 2019-01