search
Back to results

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-9674
Placebo to match GS-9674
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring Non-alcoholic fatty liver disease (NAFLD), Fibrosis, GS-9674

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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)

Key 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.

Sites / Locations

  • Ruane Clinical Research Group Inc.
  • Cedars Sinai Medical Center
  • Inland Empire Liver Foundation
  • Clinical Research of South Florida
  • Atlanta Gastroenterology Associates
  • Northwestern Memorial Hospital, Clinical Research Unit
  • Crescent Clinical Research Center, LLC
  • Tulane University Health Sciences Center
  • Kansas City Research Institute
  • Concorde Medical Group, PLLC
  • Duke University Medical Center, Duke South Clinics
  • Carolinas Center for Liver Disease/Carolinas HealthCare System
  • Thomas Jefferson University
  • Gastro One
  • Quality Medical Research, PC
  • Texas Clinical Research Institute
  • The Liver Institute at Methodist Dallas Medical Center
  • Texas Digestive Disease Consultants
  • Houston Methodist Hospital
  • Pinnacle Clinical Research
  • American Research Corporation at the Texas Liver Institute
  • Intermountain Liver Disease and Transplant Center
  • Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
  • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
  • McGuire VA Medical Center
  • Swedish Organ Transplant and Liver Center
  • University of Calgary
  • LMC Clinical Research Inc (Bayview)
  • Toronto General Hospital
  • Toronto Liver Center
  • Toronto Digestive Disease Associates, Inc.
  • Princess Margaret Hospital
  • The Chinese University of Hong Kong
  • Auckland Clinical Studies
  • Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
  • Universitatsspital Zurich
  • Addenbrooke's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

GS-9674 30 mg

GS-9674 100 mg

Placebo

Arm Description

GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks

Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2016
Last Updated
January 7, 2019
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02854605
Brief Title
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)
Keywords
Non-alcoholic fatty liver disease (NAFLD), Fibrosis, GS-9674

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GS-9674 30 mg
Arm Type
Experimental
Arm Description
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Arm Title
GS-9674 100 mg
Arm Type
Experimental
Arm Description
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9674
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match GS-9674
Intervention Description
Tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 24 weeks plus 30 days
Title
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Description
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.
Time Frame
Up to 24 weeks plus 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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) Key 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Memorial Hospital, Clinical Research Unit
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Crescent Clinical Research Center, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Concorde Medical Group, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center, Duke South Clinics
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolinas Center for Liver Disease/Carolinas HealthCare System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Quality Medical Research, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pinnacle Clinical Research
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Intermountain Liver Disease and Transplant Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Swedish Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
LMC Clinical Research Inc (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Facility Name
Auckland Clinical Studies
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32115759
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

We'll reach out to this number within 24 hrs