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    Clinical Trial Results:
    A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels >=500 mg/dL and <2000 mg/dL and Normal Renal Function.

    Summary
    EudraCT number
    2015-003511-37
    Trial protocol
    HU   CZ   BG   PL  
    Global end of trial date
    24 Jun 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jul 2020
    First version publication date
    05 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    K-877-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03001817
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Kowa Research Institute, Inc.
    Sponsor organisation address
    430 Davis Drive, Suite 200, Morrisville, United States, 27560
    Public contact
    Regulatory Affairs, Kowa Research Institute, Inc., 1 919-433-1600,
    Scientific contact
    Regulatory Affairs, Kowa Research Institute, Inc., 1 919-433-1600,
    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
    17 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate the efficacy of K-877 0.2 mg twice daily compared to placebo from baseline to Week 12 in lowering fasting triglyceride (TG) levels in patients with fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L).
    Protection of trial subjects
    The study was conducted in accordance with the World Medical Association Declaration of Helsinki; ICH GCP; General Data Protection Regulation or Directive 2001/20/EC (in the EU); the FDA GCP, as described in 21 CFR Parts 11, 50, 54, 56, and 312 and Health Insurance Portability and Accountability Act (in the US); and the laws and regulations of the country where the study was conducted. Prior to the initiation of any study procedures, each patient signed and dated an approved informed consent form. Each patient was assured of his/her right to withdraw from the study at any time.
    Background therapy
    -
    Evidence for comparator
    Fenofibrate (145 mg once daily) was chosen as the active comparator for the 40-week Extension Period of this study based on current guidelines for the management of severe hypertriglyceridemia.
    Actual start date of recruitment
    28 Nov 2016
    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
    Ukraine: 58
    Country: Number of subjects enrolled
    United States: 141
    Country: Number of subjects enrolled
    Belarus: 58
    Country: Number of subjects enrolled
    Bulgaria: 41
    Country: Number of subjects enrolled
    Czech Republic: 33
    Country: Number of subjects enrolled
    Georgia: 37
    Country: Number of subjects enrolled
    Hungary: 44
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Russian Federation: 114
    Worldwide total number of subjects
    551
    EEA total number of subjects
    143
    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)
    527
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Eligible patients entered a 4- to 6-week lifestyle stabilization period. The stabilization period was followed by a 2-week TG qualifying period and patient eligibility was assessed based on the visits in this period.

    Period 1
    Period 1 title
    12-week Efficacy
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Key results from lipid parameters were blinded prior to Week 16. Investigators received an alert for TG levels >2000 mg/dL (22.60 mmol/L) at any time during the study as well as a sham alert for TG elevation during the 12-week Efficacy Period to ensure study blinding was maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    K-877
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pemafibrate
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.2 mg BID

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo matching K-877
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo BID

    Number of subjects in period 1
    K-877 Placebo
    Started
    368
    183
    Completed
    350
    176
    Not completed
    18
    7
         Protocol deviation
    -
    1
         Persistent significant abnormal laboratory values
    -
    1
         Adverse event, non-fatal
    6
    2
         Consent withdrawn by subject
    9
    3
         Lost to follow-up
    3
    -
    Period 2
    Period 2 title
    40-week Extension
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Starting at Visit 7 (Week 12), patients received an oral dose of K-877 0.2 mg BID and placebo matching fenofibrate once daily, or fenofibrate 145 mg once daily and placebo matching K-877 BID with double dummy techniques.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    K-877
    Arm description
    Patients randomized to receive K-877 0.2 mg BID in the 12-week Efficacy Period continued to receive K-877 0.2 mg BID, as well as placebo matching fenofibrate 145 mg once daily, in the 40-week Extension Period.
    Arm type
    Experimental and Placebo Comparator

    Investigational medicinal product name
    Pemafibrate
    Investigational medicinal product code
    K-877
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.2 mg BID

    Investigational medicinal product name
    Placebo matching fenofibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo once daily over-encapsulated for double dummy techniques

    Arm title
    Placebo/Fenofibrate
    Arm description
    Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period received fenofibrate 145 mg once daily and placebo matching K-877 0.2 mg BID in the 40-week Extension Period.
    Arm type
    Active Comparator and Placebo

    Investigational medicinal product name
    Fenofibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    145 mg once daily over-encapsulated for double dummy techniques

    Investigational medicinal product name
    Placebo matching K-877
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo BID

    Number of subjects in period 2
    K-877 Placebo/Fenofibrate
    Started
    350
    176
    Completed
    335
    163
    Not completed
    15
    14
         Use of prohibited medication
    -
    1
         Persistent significant abnormal laboratory values
    1
    1
         Adverse event, serious fatal
    3
    -
         Adverse event, non-fatal
    -
    2
         Consent withdrawn by subject
    5
    8
         Lost to follow-up
    6
    2
    Joined
    0
    1
         Protocol Deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    K-877
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    K-877 Placebo Total
    Number of subjects
    368 183 551
    Age categorical
    Units: Subjects
        18-64 years
    351 176 527
        65-84 years
    17 7 24
        ≥85 years
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    97 39 136
        Male
    271 144 415
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS consisted of all randomized patients who took at least 1 dose of double-blind study drug and had a baseline TG measurement.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Analysis Set included all randomized patients who received at least 1 dose of study drug.

    Subject analysis sets values
    Full Analysis Set (FAS) Safety Analysis Set
    Number of subjects
    551
    551
    Age categorical
    Units: Subjects
        18-64 years
    527
        65-84 years
    24
        ≥85 years
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    136
        Male
    415

    End points

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    End points reporting groups
    Reporting group title
    K-877
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -
    Reporting group title
    K-877
    Reporting group description
    Patients randomized to receive K-877 0.2 mg BID in the 12-week Efficacy Period continued to receive K-877 0.2 mg BID, as well as placebo matching fenofibrate 145 mg once daily, in the 40-week Extension Period.

    Reporting group title
    Placebo/Fenofibrate
    Reporting group description
    Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period received fenofibrate 145 mg once daily and placebo matching K-877 0.2 mg BID in the 40-week Extension Period.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS consisted of all randomized patients who took at least 1 dose of double-blind study drug and had a baseline TG measurement.

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Analysis Set included all randomized patients who received at least 1 dose of study drug.

    Primary: Percent Change of Fasting Triglyceride (TG) Levels From Baseline to Week 12

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    End point title
    Percent Change of Fasting Triglyceride (TG) Levels From Baseline to Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    K-877 Placebo
    Number of subjects analysed
    368
    183
    Units: Percent
        median (inter-quartile range (Q1-Q3))
    -56.00 (-72.08 to -32.40)
    -7.97 (-44.78 to 49.87)
    Statistical analysis title
    Hodges-Lehmann estimator with multiple imputation
    Statistical analysis description
    A pattern mixture model was used as the primary imputation method as part of the primary analysis for the Week 12 percent change from baseline in fasting TG.
    Comparison groups
    K-877 v Placebo
    Number of subjects included in analysis
    551
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Hodges-Lehmann, multiple imputation
    Confidence interval

    Secondary: Percent Change From Baseline to Week 52 in Fasting TG

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    End point title
    Percent Change From Baseline to Week 52 in Fasting TG
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    K-877 Placebo/Fenofibrate
    Number of subjects analysed
    335
    163
    Units: percent
        median (inter-quartile range (Q1-Q3))
    -57.93 (-73.76 to -31.97)
    -55.45 (-68.95 to -28.74)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 Weeks
    Adverse event reporting additional description
    Non-serious adverse events are reported in the table when frequency exceeded the threshold 5% within either reporting group. In overall period, total subjects affected by any non-serious adverse events regardless of the threshold were 167/368 (45.4%) in the K-877 group and 89/183 (48.6%) in the Placebo/Fenofibrate group.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    K-877
    Reporting group description
    Patients randomized to receive K-877 0.2 mg BID in the 12-week Efficacy Period continued to receive K-877 0.2 mg BID, as well as placebo matching fenofibrate 145 mg once daily, in the 40-week Extension Period.

    Reporting group title
    Placebo/Fenofibrate
    Reporting group description
    Patients randomized to receive placebo matching K-877 0.2 mg BID in the 12-week Efficacy Period received fenofibrate 145 mg once daily and placebo matching K-877 0.2 mg BID in the 40-week Extension Period.

    Serious adverse events
    K-877 Placebo/Fenofibrate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 368 (10.60%)
    8 / 183 (4.37%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial cancer
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergic granulomatous angiitis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb traumatic amputation
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 368 (0.54%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    3 / 368 (0.82%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dental cyst
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis chronic
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Toxic skin eruption
         subjects affected / exposed
    0 / 368 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 368 (0.54%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 368 (0.27%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    K-877 Placebo/Fenofibrate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 368 (8.70%)
    14 / 183 (7.65%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    23 / 368 (6.25%)
    5 / 183 (2.73%)
         occurrences all number
    23
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 368 (2.99%)
    11 / 183 (6.01%)
         occurrences all number
    12
    11

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Aug 2017
    • Defined inclusion criteria that patients on a low-intensity statin or not on a statin needed to meet. They were consistent with, and further clarify, the American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (2013). • Clarified eGFR criteria and procedures for screen failures and potential transfer to the other parallel study, Study K-877-303. For patients who were transferred from Study K-877-303, their Visit 1 procedures were to be skipped and a written consent was required prior to any other procedures at Visit 2. • Permitted the inclusion of patients with Type 2 Diabetes Mellitus on fixed-dose regimens insulin or insulin analogues to make this study available to a wider population. • Permitted the inclusion of patients with positive HCV antibody, but no detectable HCV RNA or evidence of active HCV infection, to exclude only patients who have evidence of active HCV infection. • Simplified thyroid exclusions for patients on replacement therapy to make them consistent for both patients on therapy or untreated. • Specified an exception for prohibited medications based on the result of the drug-drug interaction study with clarithromycin known as an inhibitor of OATP1B1, OATP1B3, and CYP3A4. • Updated precautions for coadministrating medications based on the result of the drug-drug interaction study with clopidogrel (CYP2C8 inhibitor).

    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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