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    Clinical Trial Results:
    A Double-Blind Randomized Placebo-Controlled, Parallel-Group 12 Week Study to Investigate the Effects of Epanova® Compared to Placebo and Compared to Fenofibrate on Liver Fat Content in Hypertriglyceridemic Overweight Subjects; EFFECT I

    Summary
    EudraCT number
    		 2014-003637-26
    Trial protocol
    		 SE  
    Global end of trial date
    18 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2017
    First version publication date
    21 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5881C00007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Stefan Carlsson, AstraZeneca, 46 317762017, Stefan.C.Carlsson@astrazeneca.com
    Scientific contact
    Stefan Carlsson, AstraZeneca, 46 317762017 x, Stefan.C.Carlsson@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of this study was to evaluate the efficacy of Epanova as compared to placebo with respect to reduction in liver fat content (%) in obese or overweight patients with no diabetes, but with BMI >25, serum triglycerides ≥1.7 mM, and with fatty liver (>5.5% as measured with MRI).
    Protection of trial subjects
    Treated in routine care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    52
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 4 centers in Sweden between 01 September 2015 and 26 May 2016.

    Pre-assignment
    Screening details
    		 The study duration was up to 15 weeks, consisting of an initial screening period lasting up to 2 weeks, a 12-week treatment period, and a follow-up telephone call within 1 week after the last dose of study drug. A total of 171 subjects were enrolled, and 78 subjects were randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Epanova
    Arm description
    		 Epanova 4 g/day + placebo to Fenofibrate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Epanova
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1 g capsules once daily in the morning

    Investigational medicinal product name
    Placebo to Fenofibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg capsule once daily in the morning

    Arm title
    		 Fenofibrate
    Arm description
    		 Fenofibrate 200 mg/day + placebo to Epanova
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo to Epanova
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1 g capsules once daily in the morning

    Investigational medicinal product name
    Fenofibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg capsule once daily in the morning

    Arm title
    		 Placebo
    Arm description
    		 Placebo to Epanova +placebo to Fenofibrate
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to Fenofibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg capsule once daily in the morning

    Investigational medicinal product name
    Placebo to Epanova
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1 g capsules once daily in the morning

    Number of subjects in period 1
    		Epanova Fenofibrate Placebo
    Started
    25
    27
    26
    Completed
    23
    26
    23
    Not completed
    2
    1
    3
         Adverse event, non-fatal
    1
    -
    2
         Other - reason not specified
    1
    -
    1
         Study-specifc withdrawal criteria
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 Epanova 4 g/day + placebo to Fenofibrate

    Reporting group title
    Fenofibrate
    Reporting group description
    		 Fenofibrate 200 mg/day + placebo to Epanova

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to Epanova +placebo to Fenofibrate

    Reporting group values
    		 Epanova Fenofibrate Placebo Total
    Number of subjects
    		 25 27 26 78
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age <37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 19 17 16 52
        From 65-84 years
    		 6 10 10 26
        85 years and over
    		 0 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 60 ( 7.79 ) 61.7 ( 7.78 ) 60.8 ( 7.85 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 9 12 12 33
        Male
    		 16 15 14 45
    Age, Customized
    Units: Subjects
        <50
    		 3 3 1 7
        >=50 - <65
    		 16 14 15 45
        >=65
    		 6 10 10 26

    End points

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    End points reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 Epanova 4 g/day + placebo to Fenofibrate

    Reporting group title
    Fenofibrate
    Reporting group description
    		 Fenofibrate 200 mg/day + placebo to Epanova

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to Epanova +placebo to Fenofibrate

    Subject analysis set title
    Full
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients, regardless of whether they took trial medication or not.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who were randomized to 1 of the treatment groups, and received at least 1 dose of study medication.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The subset of the Full Analysis Set who adhered to the clinical study protocol.

    Primary: Change from Baseline to Week 12 in % liver fat as assessed by MRI (Epanova versus placebo)

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    End point title
    		 Change from Baseline to Week 12 in % liver fat as assessed by MRI (Epanova versus placebo) [1]
    End point description
    To evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For the secondary endpoint, only the Epanova and placebo arms are included in the analysis
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    22
    23
    Units: ratio of % liver fat
        geometric mean (confidence interval 95%)
    0.98 (0.82 to 1.17)
    1.04 (0.95 to 1.13)
    Statistical analysis title
    		 Mixed effects model (comparison versus placebo)
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.407
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean ratio for difference
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.12

    Secondary: Change from Baseline to Week 12 in % liver fat as assessed by MRI (Epanova versus Fenofibrate)

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    End point title
    		 Change from Baseline to Week 12 in % liver fat as assessed by MRI (Epanova versus Fenofibrate) [2]
    End point description
    To evaluate the efficacy of Epanova compared to Fenofibrate with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.
    End point type
    Secondary
    End point timeframe
    12 weeks
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For the primary endpoint, only the Epanova and Fenofibrate arms are included in the analysis.
    End point values
    		 Epanova Fenofibrate
    Number of subjects analysed
    22
    26
    Units: ratio of % liver fat
        geometric mean (confidence interval 95%)
    0.98 (0.82 to 1.17)
    1.17 (0.99 to 1.37)
    Statistical analysis title
    		 Mixed effects model (active treatment)
    Comparison groups
    Epanova v Fenofibrate
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.077
    Method
    		 Mixed models analysis
    Parameter type
    		 Geometric mean ratio for difference
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.02

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from visit 2 (randomization) throughout the treatment period until Visit 4 (end of treatment).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 Epanova 4 g/day + placebo to Fenofribrate

    Reporting group title
    Fenofibrate
    Reporting group description
    		 Fenofibrate 200 mg/ day + placebo to Epanova

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to Epanova + placebo to Fenofibrate

    Serious adverse events
    		 Epanova Fenofibrate Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 27 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Epanova Fenofibrate Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 25 (48.00%)
    8 / 27 (29.63%)
    5 / 26 (19.23%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    1
    Pyrexia
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 27 (7.41%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 27 (3.70%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    2
    0
    1
    Diarrhoea
         subjects affected / exposed
    7 / 25 (28.00%)
    2 / 27 (7.41%)
    4 / 26 (15.38%)
         occurrences all number
    7
    2
    4
    Flatulence
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 27 (3.70%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    1
    Nausea
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 27 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 27 (7.41%)
    1 / 26 (3.85%)
         occurrences all number
    2
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2015
    Revision of exclusion critieria to capture the target population for the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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