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    Summary
    EudraCT Number:2016-001518-39
    Sponsor's Protocol Code Number:K-877-303
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001518-39
    A.3Full title of the trial
    A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label 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 Mild or Moderate Renal Impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of K-877 in adults with high triglycerides and reduced kidney function.
    A.4.1Sponsor's protocol code numberK-877-303
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKowa Research Institute, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKowa Research Institute, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain
    B.5.2Functional name of contact pointLourdes Herreros
    B.5.3 Address:
    B.5.3.1Street AddressCalle Agustín de Foxá 29. • 8° planta.
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28036
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917900565
    B.5.6E-maill.herreros@medpace.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameK-877
    D.3.2Product code K-877
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPemafibrate
    D.3.9.1CAS number 848259-27-8
    D.3.9.2Current sponsor codeK-877
    D.3.9.3Other descriptive nameK-877
    D.3.9.4EV Substance CodeSUB119482
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fenofibrate
    D.2.1.1.2Name of the Marketing Authorisation holderCatalent CTS LLC (Missouri, USA)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFenofibrate
    D.3.2Product code Fenofibrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENOFIBRATE
    D.3.9.1CAS number 49562-28-9
    D.3.9.4EV Substance CodeSUB07576MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fenofibrate
    D.2.1.1.2Name of the Marketing Authorisation holderCatalent CTS LLC (Missouri, USA)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFenofibrate
    D.3.2Product code Fenofibrate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENOFIBRATE
    D.3.9.1CAS number 49562-28-9
    D.3.9.4EV Substance CodeSUB07576MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number145
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe hypertriglyceridemia [fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment.
    E.1.1.1Medical condition in easily understood language
    high triglycerides
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020667
    E.1.2Term Hyperlipidemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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 TG levels in patients with fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    The secondary objectives of the study are the following:
    * To evaluate the efficacy of K-877 0.2 mg twice daily from baseline to Week 52 in lowering fasting TG levels in patients with fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment;
    * To evaluate the efficacy of K-877 0.2 mg twice daily from baseline to Week 12 and Week 52 in altering lipid parameters in patients with fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment;
    * To evaluate the safety and tolerability of K-877 0.2 mg twice daily in patients with fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) and mild or moderate renal impairment; and
    * To determine the plasma concentrations of K-877 for the purpose of use in population pharmacokinetic (PK) analysis and PK/pharmacodynamic (PD) analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
    2. Aged >=18 years;
    3. Patients receiving moderate or high-intensity statin therapy must meet one of the following criteria1 unless they have any exceptional conditions:
    a) Aged >=21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
    b) Aged >=21 years with a history of LDL-C >=190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
    c) Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
    d) Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of >=7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
    4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria:
    a) Patient does not meet any criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3 a throught 3d);
    b) Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns (including, but not limited to, examples in Appendix B), or due to partial or complete statin intolerance;
    c) Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high-intensity statin for primary prevention after considering individual risk evaluation (e.g., current LDL C ≤ 70mg/dL) and patient preference (see Appendix B);
    5. Not on lipid-altering therapy other than statins, ezetimibe, or PCSK9 inhibitors at randomization;
    a) For patients currently on statins, ezetimibe, or PCSK9 inhibitors at screening, statin, ezetimibe, or PCSK9 inhibitor dose(s) must be stable for >=6 weeks prior to Visit 1 (Week -8 or Week -6); and
    b) Patients on lipid-altering medications other than statins, ezetimibe, or PCSK9 inhibitors (e.g., bile acid sequestrants, fibrates, niacin [>100 mg/day], omega-3 fatty acids [>1000 mg/day], or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols) at the time of screening must be able to safely discontinue all such lipid­altering therapy at Visit 1 (Week -8 or Week -6);
    6. Fasting TG levels >=500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1). Note: In cases in which a patient’s mean TG level from Visit 2 and Visit 3 falls outside the required range for entry into the study but is >=450 mg/dL (5.09 mmol/L) and <500 mg/dL (5.65 mmol/L), an additional TG measurement can be collected 1 week later at Visit 3.1. If a third measurement is made at Visit 3.1, entry into the study is based on the mean of the values from Visit 2, Visit 3, and Visit 3.1;
    7. Mild to moderate renal impairment (eGFR ³30 mL/min/1.73 m2 and >=90 mL/min/1.73 m2) at Visit 1 or an unsceduled visit. Patients with an eGFR ≥ 90 mL/min/1.73 m2 at Visit 1 will be re-tested at an unscheduled visit (see Section 4.5 for details);
    a) eGFR will be calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (2009);
    8. Women of childbearing potential may be considered for enrollment if all of the following criteria are met: They are not pregnant, breastfeeding, do not plan to become pregnant during the study, and they are taking adequate contraception.
    E.4Principal exclusion criteria
    1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega­3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
    2. Body mass index (BMI) >45 kg/m2 at Visit 1;
    3. Patients with type 1 diabetes mellitus;
    4. Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1;
    5. Patients who are receiving insulin or insulin analogue treatment, except for patients on fixed-dose regimens insulin for ≥4 weeks prior to Visit 1;
    6. History of stroke (including TIA), myocardial infarction or unstable angina pectoris, life-threatening arrhythmia, or coronary revascularization within 6 months prior to Visit 1;
    7. Patients with symptomatic heart failure (New York Heart Association Class III or IV);
    8. History of chronic pancreatitis or hospitalization for acute pancreatitis within the preceding 5 years;
    9. History of gallbladder disease, unless treated with cholecystectomy or the Investigator considers the gallbladder disease not clinically significant, such that it will not impact patient safety;
    10. Patients with severe renal impairment (i.e., eGFR <30 mL/min/1.73 m2) at Visit 1 or on more than one occasion in the 6 months prior to Visit 1; eGFR will be calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (2009);
    11. Patients who are receiving dialysis at Visit 1 or who have had a kidney transplant, regardless of renal function;
    12. Patients with active, severe liver disease impacting hepatic function (e.g.hepatic cirrhosis, Child-Pugh grade B or C). Faty liver disease or nonalcoholic steatohepatitis in Child-Pugh category A is permitted;
    13. History or evidence of major and clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric, oncologic, or allergic disease that would interfere with the conduct of the study or interpretation of the data;
    14. Known familial lipoprotein lipase impairment or deficiency (Fredrickson Type I), Apo C2 deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III);
    15. History of malignancy, except patients who have been disease-free for >5 years prior to Visit 1, or whose only malignancy has been basal or squamous cell skin carcinoma;
    16. History of bariatric surgery;
    17. Systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg after 5 minutes of resting at Visit 1;
    18. Positive hepatitis B surface antigen(HBsAg) or positive hepatitis C virus (HCV) antibody serology with detectable HCV ribonucleic acid (RNA):
    a) Patients with a history of hepatitis B vaccination (Anti-HBs antibody positive) without a history of hepatitis B infection (HBsAg negative) are eligible;
    b) Patients with negative HCV RNA and no evidence of active hepatitis C infection, no evidence of liver dysfunction, and who are not on a direct acting antiviral are eligible;
    19. Known to be infected with human immunodeficiency virus (HIV) 1 or HIV 2;
    20. Known hypersensitivity or intolerance to fibrates or peroxisome proliferator­activated receptor-α agonists;
    21. Anticipation of major surgery during the study;
    22. Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management (other than statins, ezetimibe, or PCSK9 inhibitors) or risk factor modification (i.e., antihypertensive and antidiabetic medications) that has not been stable for >=4 weeks prior to Visit 1;
    23. Ongoing treatment with weight loss drugs (including over-the-counter);
    24. Ongoing treatment with cyclosporine, rifampin, or other inhibitors of OATP1B1 or OATP1B3 except for clarithromycin;
    25. Treatment with tamoxifen, estrogens, or progestins that has not been stable for >=4 weeks prior to the first TG qualifying visit (Visit 2 [Week -2]);
    26. Use of all systemic corticosteroids.
    27. Clinical evidence of hypothyroidism, thyroid hormone therapy that is not stable for >= 4 weeks prior to the first TG qualifying visit (Visit 2 [Week -2]), or patients with the following thyroid­stimulating hormone (TSH) and thyroxine (T4) levels at Visit 1:

    For completion of exclusion criteria please refer to the protocol (V2.0, 25 Aug 2017).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change in fasting TG from baseline to Week 12. Baseline for TG will be defined as the mean of Visit 4 (Day 1) and the preceding TG qualifying visit (either Visit 3 [Week -1] or Visit 3.1, if required) measurements.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints for the 12-week Efficacy Period include the following:
    • Percent change from baseline to Week 12 in remnant cholesterol (calculated as total cholesterol [TC] – low-density lipoprotein C [LDL C] – high-density lipoprotein C [HDL-C]), HDL-C, apolipoprotein (Apo) A1, and non-HDL-C;
    o Low-density lipoprotein cholesterol will be determined by preparative ultracentrifugation;
    • Percent change from baseline to Week 12 in TC, LDL-C, free fatty acids (FFAs), Apo A2, Apo B, Apo B48, Apo B100, Apo C2, Apo C3, and Apo E;
    • Change from baseline to Week 12 in fibroblast growth factor 21 (FGF21) and high­sensitivity C­reactive protein (hsCRP), and percent change from baseline to Week 12 in ion mobility analysis and lipoprotein fraction (nuclear magnetic resonance [NMR]); and
    • Percent change from baseline to Week 12 in the lipid and lipoprotein ratios of TG:HDL-C, TC:HDL-C, non­HDL­C:HDL-C, LDL-C:Apo B, Apo B:Apo A1, and Apo C3:Apo C2.
    The secondary efficacy endpoints for the 40-week Extension Period include the following:
    • Percent change from baseline to Week 52 in fasting TG;
    • Percent change from baseline to Week 52 in remnant cholesterol (calculated as TC − LDL C − HDL-C), HDL-C, Apo A1, and non-HDL-C;
    o Low-density lipoprotein cholesterol will be determined by preparative ultracentrifugation;
    • Percent change from baseline to Week 52 in TC, LDL-C, FFAs, Apo A2, Apo B, Apo B48, Apo B100, Apo C2, Apo C3, and Apo E;
    • Change from baseline to Week 52 in FGF21 and hsCRP, and percent change from baseline to Week 52 in ion mobility analysis and lipoprotein fraction (NMR); and
    • Percent change from baseline to Week 52 in the lipid and lipoprotein ratios of TG:HDL-C, TC:HDL-C, non­HDL­C:HDL-C, LDL-C:Apo B, Apo B:Apo A1, and Apo C3:Apo C2.
    Baseline for TG, TC, HDL-C, non-HDL-C, LDL-C, and remnant cholesterol will be defined as the mean of Visit 4 (Day 1) and the preceding TG qualifying visit (either Visit 3 [Week -1] or Visit 3.1, if required) measurements. Baseline for all other efficacy and safety variables will be defined as Visit 4 (Day 1). If the measurement at this visit is missing, the last measurement prior to the first dose of randomized study drug will be used.
    For patients randomized to receive placebo (in the 12-week Efficacy Period) and fenofibrate (in the 40 week Extension Period), change from Visit 7 (Week 12) in efficacy and safety variables will also be explored.

    For completion of secondary endpoints please refer to the protocol (V1.0, 13 Sep 2016).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 40 or 52 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Bulgaria
    Czech Republic
    Georgia
    Hungary
    Poland
    Russian Federation
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 336
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    F.4.2.2In the whole clinical trial 422
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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