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Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03987074
Collaborator
Novo Nordisk A/S (Industry)
109
Enrollment
18
Locations
5
Arms
11.5
Actual Duration (Months)
6.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date :
Jul 29, 2019
Actual Primary Completion Date :
Jul 13, 2020
Actual Study Completion Date :
Jul 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Semaglutide

Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) for 24 weeks

Drug: Semaglutide
Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
Experimental: Semaglutide + Firsocostat 20 mg

Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg for 24 weeks

Drug: Semaglutide
Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly

Drug: Firsocostat
Tablets administered orally once daily
Other Names:
  • GS-0976

    		•
    Experimental: Semaglutide + Cilofexor 30 mg

    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 30 mg for 24 weeks

    Drug: Semaglutide
    Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly

    Drug: Cilofexor
    Tablets administered orally once daily
    Other Names:
  • GS-9674

    		•
    Experimental: Semaglutide + Cilofexor 100 mg

    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 100 mg for 24 weeks

    Drug: Semaglutide
    Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly

    Drug: Cilofexor
    Tablets administered orally once daily
    Other Names:
  • GS-9674

    		•
    Experimental: Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg

    Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg + cilofexor 30 mg for 24 weeks

    Drug: Semaglutide
    Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly

    Drug: Firsocostat
    Tablets administered orally once daily
    Other Names:
  • GS-0976

    • Drug: Cilofexor
    Tablets administered orally once daily
    Other Names:
  • GS-9674

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [First dose date up to Week 24 plus 30 days]

      Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities [First dose date up to 24 weeks plus 30 days]

      Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Historical liver biopsy consistent with NASH with stage 2-3 fibrosis according to NASH Clinical Research Network (CRN) classification OR clinical diagnosis of nonalcoholic fatty liver disease and screening FibroTest, magnetic resonance imaging - proton density fat fraction (MRI-PDFF), and FibroScan

    • Screening laboratory parameters, as determined by central laboratory:

    • Alanine aminotransferase (ALT) ≤ 5 x upper limit of the normal range (ULN)

    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Modification of Diet in Renal Disease (MDRD) study equation

    • HbA1c ≤ 9.5%

    • International normalized ratio (INR) ≤ 1.2, unless due to therapeutic anti-coagulation therapy

    • Platelet count ≥ 100,000/μL

    • Total bilirubin < 1.3 x ULN unless alternate etiology such as Gilbert's syndrome present

    • Calcitonin ≤ 100 ng/L

    • Body Mass Index (BMI) > 23 kg/m^2 and body weight of > 60 kg

    Key Exclusion Criteria:

    • Any historical liver biopsy consistent with cirrhosis

    • Any history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding

    • Other causes of liver disease, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment

    • History of liver transplantation

    • History of hepatocellular carcinoma

    • History of pancreatitis (acute or chronic)

    • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

    • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RA) in the period from 90 days prior to the date of the Screening Visit

    • Individuals on antidiabetic medications must be on a stable dose for at least 90 days prior to the date of the Screening Visit and in the period between the date of the Screening Visit and Enrollment (Day -14)

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute for Liver Health - Arizona Liver Health Chandler Arizona United States 85224
    2 Southern California Research Centers Coronado California United States 92118
    3 University of California San Diego (UCSD) La Jolla California United States 92093
    4 Ruane Clinical Research Group, Inc Los Angeles California United States 90036
    5 Cedars Sinai Medical Center Los Angeles California United States 90048
    6 Inland Empire Clinical Trials, LLC Rialto California United States 92377
    7 Medical Associates Research Group San Diego California United States 92123
    8 Gastrointestinal Specialists of Georgia Marietta Georgia United States 30060
    9 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    10 Jubilee Clinical Research, Inc. Las Vegas Nevada United States 89109
    11 Northwell Health Manhasset New York United States 11030
    12 Gastro One Huntersville North Carolina United States 28078
    13 University Gastroenterology Providence Rhode Island United States 02905
    14 Gastro One Germantown Tennessee United States 38138
    15 Quality Medical Research, PLLC Nashville Tennessee United States 37211
    16 Texas Clinical Research Institute Arlington Texas United States 76012
    17 The Liver Institute at Methodist Dallas Medical Center Dallas Texas United States 75203
    18 American Research Corporation San Antonio Texas United States 78215

    Sponsors and Collaborators

    • Gilead Sciences
    • Novo Nordisk A/S

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03987074
    Other Study ID Numbers:
    • GS-US-454-5533
    First Posted:
    Jun 14, 2019
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Firsocostat

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in United States. The first participant was screened on 29 July 2019. The last study visit occurred on 13 July 2020.
    Pre-assignment Detail 209 participants were screened. 109 participants were enrolled. 1 participant was enrolled but was not randomized and was not included in the analysis.
    Arm/Group Title Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Arm/Group Description Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
    Period Title: Overall Study
    STARTED 21 22 22 22 21
    COMPLETED 18 20 21 18 19
    NOT COMPLETED 3 2 1 4 2

    Baseline Characteristics

    Arm/Group Title Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg Total
    Arm/Group Description Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Total of all reporting groups
    Overall Participants 21 22 22 22 21 108
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55
    (10.4)
    52
    (12.6)
    51
    (10.9)
    54
    (10.8)
    53
    (11.4)
    53
    (11.1)
    Sex: Female, Male (Count of Participants)
    Female
    15
    71.4%
    15
    68.2%
    16
    72.7%
    13
    59.1%
    15
    71.4%
    74
    68.5%
    Male
    6
    28.6%
    7
    31.8%
    6
    27.3%
    9
    40.9%
    6
    28.6%
    34
    31.5%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    1
    4.8%
    0
    0%
    1
    4.5%
    1
    4.5%
    1
    4.8%
    4
    3.7%
    Asian
    2
    9.5%
    2
    9.1%
    2
    9.1%
    1
    4.5%
    0
    0%
    7
    6.5%
    Black
    1
    4.8%
    0
    0%
    1
    4.5%
    1
    4.5%
    0
    0%
    3
    2.8%
    White
    17
    81%
    19
    86.4%
    18
    81.8%
    19
    86.4%
    19
    90.5%
    92
    85.2%
    Other
    0
    0%
    1
    4.5%
    0
    0%
    0
    0%
    1
    4.8%
    2
    1.9%
    Race/Ethnicity, Customized (Count of Participants)
    Not Hispanic or Latino
    13
    61.9%
    10
    45.5%
    17
    77.3%
    15
    68.2%
    10
    47.6%
    65
    60.2%
    Hispanic or Latino
    8
    38.1%
    12
    54.5%
    5
    22.7%
    7
    31.8%
    11
    52.4%
    43
    39.8%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
    Description Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    Time Frame First dose date up to Week 24 plus 30 days

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set included participants who received at least 1 dose of study drug.
    Arm/Group Title Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Arm/Group Description Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
    Measure Participants 21 22 22 22 21
    Number [percentage of participants]
    81.0
    385.7%
    86.4
    392.7%
    81.8
    371.8%
    72.7
    330.5%
    90.5
    431%
    2. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
    Description Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.
    Time Frame First dose date up to 24 weeks plus 30 days

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set were analyzed.
    Arm/Group Title Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Arm/Group Description Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
    Measure Participants 21 22 22 22 21
    Grade 1
    61.9
    294.8%
    63.6
    289.1%
    36.4
    165.5%
    50.0
    227.3%
    66.7
    317.6%
    Grade 2
    23.8
    113.3%
    22.7
    103.2%
    31.8
    144.5%
    18.2
    82.7%
    9.5
    45.2%
    Grade 3
    0.0
    0%
    4.5
    20.5%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Grade 4
    0.0
    0%
    0.0
    0%
    0.0
    0%
    9.1
    41.4%
    0.0
    0%

    Adverse Events

    Time Frame First dose date up to 24 weeks plus 30 days
    Adverse Event Reporting Description The Safety Analysis Set included participants who received at least 1 dose of study drug
    Arm/Group Title Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Arm/Group Description Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks. Semaglutide + Cilofexor 100 mg Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + cilofexor 100 mg tablet orally once daily with or without food for 24 weeks. Participants received semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) subcutaneously with prefilled PDS290 pen-injector once weekly for 24 weeks + firsocostat 20 mg tablet orally once daily + cilofexor 30 mg tablet orally once daily with or without food for 24 weeks.
    All Cause Mortality
    Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Serious Adverse Events
    Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/21 (4.8%) 0/22 (0%) 0/22 (0%) 1/22 (4.5%) 0/21 (0%)
    Gastrointestinal disorders
    Diarrhoea 1/21 (4.8%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Pancreatitis 0/21 (0%) 0/22 (0%) 0/22 (0%) 1/22 (4.5%) 0/21 (0%)
    Vomiting 1/21 (4.8%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Other (Not Including Serious) Adverse Events
    Semaglutide Semaglutide + Firsocostat 20 mg Semaglutide + Cilofexor 30 mg Semaglutide + Cilofexor 100 mg Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/21 (76.2%) 17/22 (77.3%) 18/22 (81.8%) 13/22 (59.1%) 17/21 (81%)
    Eye disorders
    Vision blurred 0/21 (0%) 0/22 (0%) 2/22 (9.1%) 0/22 (0%) 0/21 (0%)
    Visual impairment 0/21 (0%) 2/22 (9.1%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Gastrointestinal disorders
    Abdominal distension 0/21 (0%) 3/22 (13.6%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Abdominal pain 1/21 (4.8%) 4/22 (18.2%) 1/22 (4.5%) 1/22 (4.5%) 2/21 (9.5%)
    Abdominal pain upper 3/21 (14.3%) 1/22 (4.5%) 1/22 (4.5%) 0/22 (0%) 2/21 (9.5%)
    Constipation 2/21 (9.5%) 2/22 (9.1%) 5/22 (22.7%) 3/22 (13.6%) 5/21 (23.8%)
    Diarrhoea 5/21 (23.8%) 4/22 (18.2%) 5/22 (22.7%) 1/22 (4.5%) 3/21 (14.3%)
    Dry mouth 0/21 (0%) 2/22 (9.1%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Dyspepsia 2/21 (9.5%) 1/22 (4.5%) 2/22 (9.1%) 1/22 (4.5%) 1/21 (4.8%)
    Eructation 1/21 (4.8%) 0/22 (0%) 1/22 (4.5%) 0/22 (0%) 2/21 (9.5%)
    Gastrooesophageal reflux disease 0/21 (0%) 4/22 (18.2%) 1/22 (4.5%) 0/22 (0%) 0/21 (0%)
    Nausea 9/21 (42.9%) 3/22 (13.6%) 8/22 (36.4%) 6/22 (27.3%) 14/21 (66.7%)
    Vomiting 1/21 (4.8%) 2/22 (9.1%) 2/22 (9.1%) 1/22 (4.5%) 6/21 (28.6%)
    General disorders
    Early satiety 1/21 (4.8%) 3/22 (13.6%) 0/22 (0%) 0/22 (0%) 0/21 (0%)
    Fatigue 2/21 (9.5%) 1/22 (4.5%) 3/22 (13.6%) 1/22 (4.5%) 2/21 (9.5%)
    Pyrexia 0/21 (0%) 0/22 (0%) 0/22 (0%) 0/22 (0%) 2/21 (9.5%)
    Infections and infestations
    Gastroenteritis 0/21 (0%) 1/22 (4.5%) 0/22 (0%) 3/22 (13.6%) 1/21 (4.8%)
    Upper respiratory tract infection 1/21 (4.8%) 1/22 (4.5%) 2/22 (9.1%) 0/22 (0%) 2/21 (9.5%)
    Urinary tract infection 1/21 (4.8%) 0/22 (0%) 2/22 (9.1%) 1/22 (4.5%) 1/21 (4.8%)
    Investigations
    Blood creatine phosphokinase increased 0/21 (0%) 0/22 (0%) 0/22 (0%) 2/22 (9.1%) 1/21 (4.8%)
    Weight decreased 0/21 (0%) 0/22 (0%) 2/22 (9.1%) 2/22 (9.1%) 0/21 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 4/21 (19%) 4/22 (18.2%) 6/22 (27.3%) 0/22 (0%) 3/21 (14.3%)
    Hypoglycaemia 0/21 (0%) 2/22 (9.1%) 4/22 (18.2%) 0/22 (0%) 0/21 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 5/21 (23.8%) 0/22 (0%) 0/22 (0%) 2/22 (9.1%) 0/21 (0%)
    Nervous system disorders
    Dizziness 2/21 (9.5%) 1/22 (4.5%) 3/22 (13.6%) 2/22 (9.1%) 0/21 (0%)
    Headache 1/21 (4.8%) 3/22 (13.6%) 1/22 (4.5%) 1/22 (4.5%) 1/21 (4.8%)
    Renal and urinary disorders
    Dysuria 1/21 (4.8%) 0/22 (0%) 0/22 (0%) 1/22 (4.5%) 2/21 (9.5%)
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic 0/21 (0%) 1/22 (4.5%) 0/22 (0%) 0/22 (0%) 2/21 (9.5%)
    Skin and subcutaneous tissue disorders
    Pruritus 0/21 (0%) 0/22 (0%) 1/22 (4.5%) 2/22 (9.1%) 2/21 (9.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03987074
    Other Study ID Numbers:
    • GS-US-454-5533
    First Posted:
    Jun 14, 2019
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jun 1, 2021