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

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ClinicalTrials.gov Identifier: NCT02854605
Recruitment Status : Completed
First Posted : August 3, 2016
Results First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis (NASH)
Interventions Drug: GS-9674
Drug: Placebo to match GS-9674
Enrollment 140
Recruitment Details Participants were enrolled at study sites in North America, Hong Kong, New Zealand, and Europe. The first participant was screened on 26 October 2016. The last study visit occurred on 09 January 2018.
Pre-assignment Details 327 participants were screened.
Arm/Group Title GS-9674 100 mg GS-9674 30 mg Placebo
Hide Arm/Group Description GS-9674 100 mg tablet once daily + placebo-to-match (PTM) GS-9674 30 mg tablet once daily for 24 weeks. GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Period Title: Overall Study
Started 56 56 28
Completed 53 49 24
Not Completed 3 7 4
Reason Not Completed
Adverse Event             1             5             2
Lost to Follow-up             0             2             0
Withdrew Consent             1             0             1
Investigator's Discretion             1             0             0
Protocol Violation             0             0             1
Arm/Group Title GS-9674 100 mg GS-9674 30 mg Placebo Total
Hide Arm/Group Description GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks. GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 56 56 28 140
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 56 participants 28 participants 140 participants
55  (10.5) 51  (12.8) 50  (9.9) 53  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 28 participants 140 participants
Female
35
  62.5%
37
  66.1%
15
  53.6%
87
  62.1%
Male
21
  37.5%
19
  33.9%
13
  46.4%
53
  37.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 28 participants 140 participants
Hispanic or Latino
17
  30.4%
19
  33.9%
8
  28.6%
44
  31.4%
Not Hispanic or Latino
39
  69.6%
37
  66.1%
20
  71.4%
96
  68.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race, Customized Number Analyzed 56 participants 56 participants 28 participants 140 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   3.6%
2
   1.4%
Asian
13
  23.2%
5
   8.9%
4
  14.3%
22
  15.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   3.6%
0
   0.0%
2
   1.4%
Black or African American
1
   1.8%
1
   1.8%
1
   3.6%
3
   2.1%
White
42
  75.0%
47
  83.9%
21
  75.0%
110
  78.6%
Other
0
   0.0%
0
   0.0%
1
   3.6%
1
   0.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 28 participants 140 participants
New Zealand
1
   1.8%
2
   3.6%
1
   3.6%
4
   2.9%
Canada
12
  21.4%
7
  12.5%
6
  21.4%
25
  17.9%
Hong Kong
5
   8.9%
2
   3.6%
3
  10.7%
10
   7.1%
United States
37
  66.1%
43
  76.8%
16
  57.1%
96
  68.6%
United Kingdom
1
   1.8%
0
   0.0%
0
   0.0%
1
   0.7%
Switzerland
0
   0.0%
2
   3.6%
2
   7.1%
4
   2.9%
1.Primary Outcome
Title Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Arm/Group Title GS-9674 100 mg GS-9674 30 mg Placebo
Hide Arm/Group Description:
GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.
GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 56 56 28
Measure Type: Number
Unit of Measure: Percentage of participants
TEAEs 89.3 76.8 67.9
TEAEs leading to premature discontinuation of drug 1.8 8.9 7.1
2.Primary Outcome
Title Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GS-9674 100 mg GS-9674 30 mg Placebo
Hide Arm/Group Description:
GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks.
GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 56 56 28
Measure Type: Number
Unit of Measure: Percentage of participants
Any Grade ≥ 1 89.3 92.9 92.9
Grade 1 35.7 42.9 50.0
Grade 2 37.5 37.5 25.0
Grade 3 7.1 10.7 14.3
Grade 4 8.9 1.8 3.6
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set included all participants who took at least 1 dose of study drug.
 
Arm/Group Title GS-9674 100 mg GS-9674 30 mg Placebo
Hide Arm/Group Description GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks. GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks.
All-Cause Mortality
GS-9674 100 mg GS-9674 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/56 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GS-9674 100 mg GS-9674 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/56 (3.57%)   2/56 (3.57%)   1/28 (3.57%) 
Hepatobiliary disorders       
Bile duct stone  1  1/56 (1.79%)  0/56 (0.00%)  0/28 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Oesophageal carcinoma  1  1/56 (1.79%)  0/56 (0.00%)  0/28 (0.00%) 
B-cell lymphoma  1  0/56 (0.00%)  1/56 (1.79%)  0/28 (0.00%) 
Thyroid cancer  1  0/56 (0.00%)  1/56 (1.79%)  0/28 (0.00%) 
Reproductive system and breast disorders       
Pelvic pain  1  0/56 (0.00%)  1/56 (1.79%)  0/28 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  0/56 (0.00%)  0/56 (0.00%)  1/28 (3.57%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GS-9674 100 mg GS-9674 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/56 (69.64%)   34/56 (60.71%)   17/28 (60.71%) 
Ear and labyrinth disorders       
Vertigo  1  3/56 (5.36%)  0/56 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  2/56 (3.57%)  3/56 (5.36%)  3/28 (10.71%) 
Abdominal pain  1  5/56 (8.93%)  2/56 (3.57%)  0/28 (0.00%) 
Abdominal pain upper  1  3/56 (5.36%)  5/56 (8.93%)  1/28 (3.57%) 
Constipation  1  1/56 (1.79%)  3/56 (5.36%)  0/28 (0.00%) 
Diarrhoea  1  3/56 (5.36%)  3/56 (5.36%)  1/28 (3.57%) 
Dry mouth  1  1/56 (1.79%)  1/56 (1.79%)  2/28 (7.14%) 
Dyspepsia  1  1/56 (1.79%)  0/56 (0.00%)  2/28 (7.14%) 
Gastritis  1  0/56 (0.00%)  0/56 (0.00%)  2/28 (7.14%) 
Nausea  1  2/56 (3.57%)  4/56 (7.14%)  2/28 (7.14%) 
General disorders       
Fatigue  1  2/56 (3.57%)  7/56 (12.50%)  1/28 (3.57%) 
Infections and infestations       
Bronchitis  1  3/56 (5.36%)  3/56 (5.36%)  0/28 (0.00%) 
Nasopharyngitis  1  1/56 (1.79%)  3/56 (5.36%)  3/28 (10.71%) 
Sinusitis  1  1/56 (1.79%)  3/56 (5.36%)  0/28 (0.00%) 
Upper respiratory tract infection  1  6/56 (10.71%)  5/56 (8.93%)  2/28 (7.14%) 
Urinary tract infection  1  4/56 (7.14%)  0/56 (0.00%)  1/28 (3.57%) 
Injury, poisoning and procedural complications       
Arthropod bite  1  0/56 (0.00%)  0/56 (0.00%)  2/28 (7.14%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/56 (0.00%)  0/56 (0.00%)  2/28 (7.14%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  2/56 (3.57%)  4/56 (7.14%)  3/28 (10.71%) 
Myalgia  1  3/56 (5.36%)  1/56 (1.79%)  1/28 (3.57%) 
Nervous system disorders       
Dizziness  1  1/56 (1.79%)  1/56 (1.79%)  2/28 (7.14%) 
Headache  1  4/56 (7.14%)  6/56 (10.71%)  4/28 (14.29%) 
Psychiatric disorders       
Depression  1  1/56 (1.79%)  5/56 (8.93%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  13/56 (23.21%)  9/56 (16.07%)  5/28 (17.86%) 
Pruritus generalised  1  3/56 (5.36%)  3/56 (5.36%)  0/28 (0.00%) 
Vascular disorders       
Hypertension  1  3/56 (5.36%)  1/56 (1.79%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02854605     History of Changes
Other Study ID Numbers: GS-US-402-1852
2016-002496-10 ( EudraCT Number )
First Submitted: July 29, 2016
First Posted: August 3, 2016
Results First Submitted: January 7, 2019
Results First Posted: January 29, 2019
Last Update Posted: January 29, 2019