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    Clinical Trial Results:
    A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels

    Summary
    EudraCT number
    		 2013-001517-32
    Trial protocol
    		 SE   GB   HU   DE   CZ   NL   DK   PL  
    Global end of trial date
    23 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    01 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    K-877-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kowa Research Europe Ltd
    Sponsor organisation address
    105 Wharfedale Road, Winnersh Triangle, Wokingham, United Kingdom, RG41 5RB
    Public contact
    Regulatory Affairs, Kowa Research Europe Ltd, +44 0118 922 9000,
    Scientific contact
    Regulatory Affairs, Kowa Research Europe Ltd, +44 0118 922 9000,
    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
    20 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the dose response of the following parameters: •% change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12 •% change in TG from baseline to Week 12 To assess the safety and tolerability of K-877 in patients with residual cardiovascular risk despite statin-controlled low density lipoprotein (LDL-C) concentration as particularly evaluated by: •Change and % change in serum creatinine from baseline to Week 12 •Change and % change in log(homocysteine) from baseline to Week 12
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. Each patient was assured of his/her right to withdraw from the study at any time. Close monitoring of all subjects was adhered to throughout the trial conduct. Throughout the study, patients were not allowed to change the dose, dosing regimen (e.g. morning or evening dose), or the type of statin and encouraged to continue on the same diet and exercise regimen. In general, any other medication not excluded by the protocol was permitted.
    Background therapy
    		 Stable statin therapy (except for pravastatin, lovastatin, and fluvastatin)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2013
    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
    Poland: 31
    Country: Number of subjects enrolled
    Netherlands: 56
    Country: Number of subjects enrolled
    Sweden: 19
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Czech Republic: 38
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 93
    Country: Number of subjects enrolled
    Russian Federation: 116
    Worldwide total number of subjects
    408
    EEA total number of subjects
    292
    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)
    273
    From 65 to 84 years
    135
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The Screening Period was up to a maximum of 4 weeks in duration and consisted of 1 or 2 visits: Screening Visit (SV) 1 for all patients, and SV 2 for patients who failed to meet inclusion criterion #5 (fasting TG ≥175 mg/dL [1.97 mmol/L] and ≤500 mg/dL [5.65 mmol/L]) at SV 1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo twice daily
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two placebo tablets were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.05 mg twice daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.05 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.05 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.05 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.1 mg twice daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.1 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.1 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.1 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.2 mg twice daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.2 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.2 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One K-877 0.2 mg tablet and one placebo tablet were to be taken orally, twice daily in the morning and the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.1 mg once daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.05 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.05 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.05 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.2 mg once daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.1 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.1 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.1 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Arm title
    		 K-877 0.4 mg once daily
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    K-877 0.2 mg tablet
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.2 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Investigational medicinal product name
    Placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two K-877 0.2 mg tablets were to be taken orally in the morning and two placebo tablets were to be taken orally in the evening. Duration of treatment was 12 weeks.

    Number of subjects in period 1
    		Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Started
    60
    58
    58
    57
    58
    58
    59
    Completed
    55
    54
    50
    52
    54
    56
    54
    Not completed
    5
    4
    8
    5
    4
    2
    5
         Consent withdrawn by subject
    3
    4
    3
    2
    2
    1
    3
         Adverse event, non-fatal
    1
    -
    2
    3
    2
    1
    1
         Lost to follow-up
    -
    -
    2
    -
    -
    -
    -
         Protocol deviation
    1
    -
    1
    -
    -
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.05 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.4 mg once daily
    Reporting group description
    		 -

    Reporting group values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily Total
    Number of subjects
    		 60 58 58 57 58 58 59 408
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 38 39 40 37 43 37 39 273
        From 65-84 years
    		 22 19 18 20 15 21 20 135
        85 years and over
    		 0 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61 ± 10.3 59 ± 9.8 58 ± 12.3 61 ± 8.9 57 ± 9.7 59 ± 11.7 59 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 17 18 18 17 24 18 14 126
        Male
    		 43 40 40 40 34 40 45 282

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.05 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.4 mg once daily
    Reporting group description
    		 -

    Primary: Percent change in TG

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    End point title
    		 Percent change in TG
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    55
    52
    50
    49
    50
    52
    52
    Units: percent
        least squares mean (standard error)
    15 ± 4.85
    -21.2 ± 4.96
    -30.8 ± 5.08
    -39.5 ± 5.11
    -19.1 ± 4.98
    -22.7 ± 4.88
    -27.7 ± 4.99
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.5
         upper limit
    		 -18.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.72
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -45.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -63.4
         upper limit
    		 -28.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.81
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -54.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -72.1
         upper limit
    		 -36.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.83
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.5
         upper limit
    		 -16.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.76
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -37.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55
         upper limit
    		 -20.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.72
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -42.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -60.1
         upper limit
    		 -25.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.75

    Primary: Percent change in non-HDL-C

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    End point title
    		 Percent change in non-HDL-C
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    55
    52
    50
    49
    50
    52
    52
    Units: percent
        least squares mean (standard error)
    2.1 ± 2.9
    -4.8 ± 2.98
    -5.4 ± 3.04
    -6.8 ± 3.05
    -3.2 ± 2.96
    -7.1 ± 2.88
    -5.7 ± 2.99
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.8
         upper limit
    		 3.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.87
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.237
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.5
         upper limit
    		 2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.91
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.111
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19
         upper limit
    		 1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.91
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.582
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.3
         upper limit
    		 4.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.88
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.086
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.1
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.85
    Statistical analysis title
    		 Dunnett's Test in MMRM Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.187
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.87

    Primary: Percent change in serum creatinine

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    End point title
    		 Percent change in serum creatinine
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    1.13 ± 1.41
    1.53 ± 1.43
    1.82 ± 1.46
    4.92 ± 1.46
    1.15 ± 1.4
    3.02 ± 1.36
    3.56 ± 1.43
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.824
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.19
         upper limit
    		 4.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.83
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.706
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 4.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.85
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 7.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.85
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.989
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.55
         upper limit
    		 3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.82
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.297
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 5.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.81
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.185
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 6.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.84

    Primary: Percent change in Log(Homocysteine)

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    End point title
    		 Percent change in Log(Homocysteine)
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    3 ± 1.14
    2.9 ± 1.16
    5.89 ± 1.18
    8.45 ± 1.18
    3.93 ± 1.13
    5.91 ± 1.1
    8.37 ± 1.15
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.948
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.01
         upper limit
    		 2.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.48
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.054
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 5.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.49
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.51
         upper limit
    		 8.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.49
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.529
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 3.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 5.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.46
         upper limit
    		 8.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.48

    Secondary: Percent change in HDL-C

    		 Close Top of page
    End point title
    		 Percent change in HDL-C
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    -0.05 ± 2.69
    7.59 ± 2.73
    12.84 ± 2.8
    10.89 ± 2.78
    3.66 ± 2.66
    10.32 ± 2.6
    7.29 ± 2.73
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 14.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.94
         upper limit
    		 19.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.53
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.01
         upper limit
    		 17.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.53
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.12
         upper limit
    		 10.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.48
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.55
         upper limit
    		 17.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.47
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 14.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.5

    Secondary: Percent change in total cholesterol

    		 Close Top of page
    End point title
    		 Percent change in total cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    0.65 ± 2.1
    -1.42 ± 2.12
    -1.99 ± 2.17
    -3.13 ± 2.17
    -1.67 ± 2.07
    -2.12 ± 2.02
    -1.68 ± 2.12
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.446
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.43
         upper limit
    		 3.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.72
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.338
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.05
         upper limit
    		 2.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.75
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.19
         upper limit
    		 1.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.75
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.392
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.64
         upper limit
    		 3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.71
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.306
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.07
         upper limit
    		 2.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.7
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.393
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.68
         upper limit
    		 3.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.72

    Secondary: Percent change in Remnant Cholesterol

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    End point title
    		 Percent change in Remnant Cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    22.25 ± 6.08
    -13.3 ± 6.16
    -26.6 ± 6.3
    -35.8 ± 6.29
    -17.6 ± 6.01
    -23.6 ± 5.87
    -23.2 ± 6.18
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -35.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.1
         upper limit
    		 -20
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.89
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -48.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -64.5
         upper limit
    		 -33.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.98
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -73.7
         upper limit
    		 -42.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.97
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -39.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -55.3
         upper limit
    		 -24.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.84
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -45.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -61.2
         upper limit
    		 -30.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.82
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -45.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -61.1
         upper limit
    		 -29.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.93

    Secondary: Percent change in LDL-C

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    End point title
    		 Percent change in LDL-C
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    54
    57
    58
    56
    Units: percent
        least squares mean (standard error)
    -3.01 ± 3.56
    5 ± 3.61
    13.06 ± 3.68
    17.49 ± 3.7
    6.18 ± 3.52
    8.21 ± 3.43
    12.65 ± 3.62
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 17.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.62
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    16.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.88
         upper limit
    		 25.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.67
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.3
         upper limit
    		 29.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.67
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.046
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 18.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.59
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.21
         upper limit
    		 20.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.58
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.55
         upper limit
    		 24.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.63

    Secondary: Percent change in apolipoprotein A1

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    End point title
    		 Percent change in apolipoprotein A1
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    52
    57
    57
    56
    Units: percent
        least squares mean (standard error)
    1.82 ± 1.9
    6.25 ± 1.93
    4.78 ± 1.97
    2.23 ± 1.99
    1.72 ± 1.88
    3.71 ± 1.86
    4.47 ± 1.93
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 9.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.47
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.234
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.93
         upper limit
    		 7.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.49
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.871
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.53
         upper limit
    		 5.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.51
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.969
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.92
         upper limit
    		 4.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.45
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.441
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.94
         upper limit
    		 6.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.46
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.284
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 7.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.47

    Secondary: Percent change in apolipoprotein B

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    End point title
    		 Percent change in apolipoprotein B
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    52
    57
    57
    56
    Units: percent
        least squares mean (standard error)
    0.48 ± 2.94
    2.2 ± 2.99
    -0.23 ± 3.05
    -2.71 ± 3.1
    -1.62 ± 2.91
    -0.57 ± 2.87
    -0.89 ± 2.98
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    K-877 0.05 mg twice daily v Placebo twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.653
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.81
         upper limit
    		 9.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.83
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.855
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 6.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.86
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.415
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.9
         upper limit
    		 4.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.91
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.582
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.57
         upper limit
    		 5.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.783
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.53
         upper limit
    		 6.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.8
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.721
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 6.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.83

    Secondary: Percent change in apolipoprotein C3

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    End point title
    		 Percent change in apolipoprotein C3
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to Week 12
    End point values
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Number of subjects analysed
    56
    56
    54
    52
    57
    57
    56
    Units: percent
        least squares mean (standard error)
    5.13 ± 3.85
    -10.3 ± 3.9
    -23.6 ± 3.98
    -30.8 ± 4.04
    -12 ± 3.82
    -19.2 ± 3.75
    -18.6 ± 3.92
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.05 mg twice daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.3
         upper limit
    		 -5.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    5
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg twice daily
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -28.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.6
         upper limit
    		 -18.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.05
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg twice daily
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46
         upper limit
    		 -25.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.1
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.1 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -17.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.9
         upper limit
    		 -7.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.99
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.2 mg once daily
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.1
         upper limit
    		 -14.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.97
    Statistical analysis title
    		 ANCOVA Analysis
    Comparison groups
    Placebo twice daily v K-877 0.4 mg once daily
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -23.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.6
         upper limit
    		 -13.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.01

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were to be reported from signing of the Informed Consent Form until the last study visit. Serious adverse events were to be collected from signing of the Informed Consent Form until 30 days after the last dose of study medication.
    Adverse event reporting additional description
    Only treatment-emergent adverse events (i.e. events not present prior to the initiation of the study drugs or events already present that worsens in either intensity or frequency following exposure to the study drugs) are summerised here.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.05 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg twice daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.1 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.2 mg once daily
    Reporting group description
    		 -

    Reporting group title
    K-877 0.4 mg once daily
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    1 / 57 (1.75%)
    3 / 58 (5.17%)
    2 / 58 (3.45%)
    2 / 59 (3.39%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal polyp
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo twice daily K-877 0.05 mg twice daily K-877 0.1 mg twice daily K-877 0.2 mg twice daily K-877 0.1 mg once daily K-877 0.2 mg once daily K-877 0.4 mg once daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 60 (56.67%)
    29 / 57 (50.88%)
    21 / 58 (36.21%)
    30 / 57 (52.63%)
    22 / 58 (37.93%)
    29 / 58 (50.00%)
    30 / 59 (50.85%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    4 / 58 (6.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    1
    0
    1
    4
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 57 (0.00%)
    2 / 58 (3.45%)
    4 / 57 (7.02%)
    2 / 58 (3.45%)
    3 / 58 (5.17%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    2
    4
    2
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 60 (8.33%)
    1 / 57 (1.75%)
    0 / 58 (0.00%)
    3 / 57 (5.26%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    5
    1
    0
    3
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 57 (0.00%)
    3 / 58 (5.17%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    3
    0
    1
    1
    1
    Back pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 57 (1.75%)
    4 / 58 (6.90%)
    0 / 58 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    0
    1
    4
    0
    2
    Muscle spasms
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    3 / 57 (5.26%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    0
    3
    0
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 57 (1.75%)
    1 / 58 (1.72%)
    5 / 57 (8.77%)
    2 / 58 (3.45%)
    4 / 58 (6.90%)
    4 / 59 (6.78%)
         occurrences all number
    3
    1
    1
    5
    2
    4
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 57 (1.75%)
    1 / 58 (1.72%)
    1 / 57 (1.75%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
    4 / 59 (6.78%)
         occurrences all number
    2
    1
    1
    1
    2
    1
    4
    Influenza
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 57 (1.75%)
    3 / 58 (5.17%)
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    3
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 57 (3.51%)
    1 / 58 (1.72%)
    0 / 57 (0.00%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
    3 / 59 (5.08%)
         occurrences all number
    3
    2
    1
    0
    1
    3
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2013
    The protocol was amended to modify the followings. - Diaphragm with spermicide as an effective method of contraception for male or female study participants was removed from the inclusion criteria. - The inclusion criteria was added to require male study participants to use a condom with a spermicide during sexual intercourse, from screening to the end of the study, even if their sexual partner is or may be pregnant. - Subgroup analyses and non-compartmental PK analysis methods were added to the statistical analyses.
    18 Mar 2014
    The protocol was amended to allow for the inclusion of subjects who are taking the maximum tolerated dose of statin and still have not reached the LDL-C targets as defined in the protocol.

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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