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    Summary
    EudraCT Number:2015-004136-36
    Sponsor's Protocol Code Number:1002-040
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-14
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2015-004136-36
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER LONG-TERM SAFETY AND TOLERABILITY STUDY OF ETC-1002 IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK WHO ARE NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term ( 52 week) study to assess the safety and tolerability of investigational drug ETC-1002 when compared with Placebo, in patients with hyperlipidemia (high LDL cholesterol ), who are at high risk of heart problems and who are also receiving the highest dose of lipid modifying treatment that they can tolerate. Patients will be randomly allocated to either placebo or investigational drug; assignment will be unknown to patients and their doctor.
    A.3.2Name or abbreviated title of the trial where available
    CLEAR Harmony
    A.4.1Sponsor's protocol code number1002-040
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02666664
    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 SponsorEsperion Therapeutics, 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 supportEsperion Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact point1002-040 Project Management
    B.5.3 Address:
    B.5.3.1Street Address7405 Transcanada Hwy, Suite 300
    B.5.3.2Town/ citySt. Laurent, Montreal, Quebec
    B.5.3.3Post codeH4T 1Z2
    B.5.3.4CountryCanada
    B.5.4Telephone number+1215 616 3540
    B.5.5Fax number+1514332-0710
    B.5.6E-mailMartin.Lucas@iconplc.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 namebempedoic acid 180mg Tablets
    D.3.2Product code ETC-1002
    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 INNBempedoic acid
    D.3.9.1CAS number 738606-46-7
    D.3.9.2Current sponsor codeETC-1002
    D.3.9.3Other descriptive nameESP55016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    Treatment of high cardiovascular risk patients (heterozygous familial hypercholesterolemia [HeFH] and atherosclerotic cardiovascular diseases [ASCVD]) with hyperlipidemia
    E.1.1.1Medical condition in easily understood language
    Treatment of hyperlipidemia; a condition where there is an excess of lipids (fats e.g. cholesterol ) in the blood, in patients with a high risk of developing heart problems.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057079
    E.1.2Term Heterozygous familial hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Safety Objective:
    To evaluate the long-term safety and tolerability of ETC-1002 versus placebo in high cardiovascular (CV) risk patients with hyperlipidemia (with underlying HeFH and/or ASCVD) who are not adequately controlled with their maximally tolerated lipid-modifying therapy.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objective:
    To assess percent change from baseline to Week 12 in LDL-C
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient with hyperlipidemia must meet the following criteria to be randomized in this study:
    1. Age ≥18 years or legal age of majority based on regional law, whichever is greater at Week -2 (Visit S1)
    2. Men and nonpregnant, nonlactating women. Women must be either:
    • Naturally postmenopausal (as reported by the patient, defined as greater than 55 years and ≥1 year without menses, less than 55 years and ≥1 year without menses with follicle-stimulating hormone (FSH) ≥40.0 IU/L), or surgically sterile including hysterectomy, bilateral oophorectomy, or tubal ligation or;
    • Women of childbearing potential must be willing to use 1 acceptable method of birth control. The minimal requirement for adequate contraception it is that it should be started on Day 1, continuing during the study period, and for at least 30 days after the last dose of study drug. Acceptable methods of birth control include: oral birth control medications; placement of an intrauterine device (IUD) with or without hormones; barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly; vasectomized male partner who is the sole partner for this patient; or true abstinence (not including periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods, or withdrawal).
    • There are no protocol-specific birth control requirements for men with partners who are able to become pregnant.
    3. Fasting LDL-C value at Week -2 (Visit S1) ≥70 mg/dL (1.8 mmol/L).
    Note: LDL-C may be repeated 1 time with the screening period extended up to 2 weeks. For those patients who have a repeat LDL-C, the mean of the first value and the repeat value will be used to determine eligibility.
    4. Have high cardiovascular risk that is defined as either:
    • Diagnosis of HeFH. Diagnosis must be made by either genotyping or by clinical assessment using either the World Health Organization (WHO) criteria/Dutch Lipid Clinical Network Criteria with a score that is >8 points or the Simon Broome Register Diagnostic Criteria with an assessment of ‘Definite HeFH’. Patients with a diagnosis of HeFH may or may not have established CHD or CHD risk equivalents.
    OR
    • Have ASCVD (with established CHD or CHD risk equivalents)
    Documented history of CHD (includes 1 or more of the following):
    - Acute myocardial infarction (MI)
    - Silent MI
    - Unstable angina
    - Coronary revascularization procedure (eg, percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery)
    - Clinically significant CHD diagnosed by invasive or non-invasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography or nuclear imaging)
    Documented CHD risk equivalents (includes 1 or more of the following criteria):
    - Peripheral arterial disease
    - Previous ischemic stroke with a focal ischemic neurological deficit that persisted more than 24 hours, considered as being of atherothrombotic origin. Computed tomography (CT) or magnetic resonance imaging (MRI) must have been performed to rule out hemorrhage and non-ischemic neurological disease
    Note: Patients with type 2 diabetes mellitus (T2DM) are allowed in this study; however for this study T2DM is not considered a CHD risk equivalent
    5. Be on maximally tolerated lipid-modifying therapy, including a maximally tolerated statin either alone or in combination with other lipid-lowering therapies, at stable doses for at least 4 weeks prior to screening (6 weeks for fibrates; however, gemfibrozil is not allowed). Regimens other than daily dosing, including those at very low doses, are acceptable.
    A patient’s maximally tolerated lipid-modifying therapy will be determined by the investigator using their medical judgment and available sources, including the patient’s self-reported history of lipid-modifying therapy.
    E.4Principal exclusion criteria
    1. Total fasting triglyceride ≥500 mg/dL (5.6 mmol/L) at Wk -2 (Visit S1)
    2. Renal dysfunction or nephritic syndrome or a history of nephritis, including eGFR (using central laboratory determined MDRD formula) <30 mL/min/1.73 m2 at Wk -2 (Visit S1).
    Note: Also excluded are renally impaired patients receiving an average daily dose of simvastatin 40 mg with eGFR below <45 mL/min/1.73 m2.
    3. BMI ≥50 kg/m2
    4. Concomitant use of simvastatin at average daily doses greater than 40 mg.
    5. Concomitant use of a PCSK inhibitor (alirocumab or evolocumab) at Wk -2 (Visit S1) or prior use of a PCSK9 inhibitor within the past 4 weeks of Wk -2 (Visit S1) will be excluded from this study.
    6. Recent (within 3 months prior to the screening visit [Wk -2 (Visit S1)] or between screening and randomization visits) MI, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia (or medication for an arrhythmia that was started or dose changed within 3 months of screening), CABG, PCI, carotid surgery or stenting, cerebrovascular accident, TIA, endovascular procedure or surgical intervention for peripheral vascular disease or plans to undergo a major surgical or interventional procedure (eg, PCI, CABG, carotid or peripheral revascularization). Patients with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months.
    7. Uncontrolled hypertension, defined as sitting SBP ≥160 mmHg and DBP ≥100 mmHg after sitting quietly for 5 minutes.
    8. HbA1C ≥10% at Wk -2 (Visit S1)
    9. Uncontrolled hypothyroidism, including TSH >1.5 × ULN at Wk -2 (Visit S1). Patients stabilized on thyroid replacement therapy for at least 6 wks prior to randomization are allowed.
    10. Liver disease or dysfunction, including:
    • Positive serology for HBsAg and/or HCV AB at Wk -2 (Visit S1); or
    • ALT, AST ≥2 × ULN, and/or total bilirubin ≥1.2 × ULN at Wk -2 (Visit S1).
    Note: If HCV AB is positive, a reflex HCV RNA will be performed to rule out active disease. Patients without active disease may be enrolled the study.
    If TB ≥1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained and if consistent with Gilbert’s disease, the patient may be enrolled in the study.
    11. GI conditions or procedures (including weight loss surgery; eg, Lap-Band® or gastric bypass) that may affect drug absorption
    12. Hematologic or coagulation disorders or a Hgb level <10.0 g/dL (100 g/L) at Wk -2 (Visit S1)
    13. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 yrs. Patients with a history of nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed.
    14. Unexplained creatine kinase (CK) >3 × ULN at screening up to randomization (ie, not associated with recent trauma or physically strenuous activity). Patients with an explained CK elevation must have single repeat CK ≤3 × ULN prior to randomization.
    15. History within the last 2 yrs of drug, alcohol, amphetamine and derivatives, or cocaine abuse. Patients with amphetamine derivatives prescribed by and under the care of a health care practitioner can be enrolled after evaluation by the Investigator.
    16. Blood donation, blood transfusion for any reason, participation in a clinical study with multiple blood draws, major trauma, or surgery with or without blood loss within 30 days prior to randomization
    17. Use of any experimental or investigational drugs within 30 days prior to screening or 5 half-lives, whichever is longer
    18. Prior participation in a previous ETC 1002 clinical study. Prior participation in a clinical study with ETC 1002 is defined as having been enrolled in an ETC 1002 study.
    19. Use of any of the following drugs within 3 months prior to screening or a plan to use these drugs during the study;
    • New or planned dose changes of systemic corticosteroids
    • Requirement for mipomersen or lomitapide or apheresis therapy
    20. Planned initiation of the following drugs during the clinical trial or changes to the following drugs prior to randomization:
    • Hormone replacement (6 wks prior to randomization)
    • Thyroid replacement (6 wks prior to randomization)
    • Diabetes medications (4 wks prior to randomization)
    • Obesity medication (3 months prior to randomization)
    21. An employee or contractor of the facility conducting the study, or a family member of the PI, Co-I, or Sponsor
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is general safety, which includes AEs, clinical safety laboratories, PEs, vital signs, and ECGs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    •TEAEs, SAEs and clinical endpoints will be collected as they occur.
    •Clinical safety laboratories; PE findings; vital signs; ECG readings; and weight will be recorded at baseline and each post-baseline time point (treatment visit - every 4 weeks then every 12 weeks), as will liver associated enzymes and total bilirubin.
    •Creatinine kinase levels and eGFR (as measures of muscoskeletal and renal safety) will be recorded at baseline and each visit.
    E.5.2Secondary end point(s)
    Percent change from baseline to Week 12 in LDL-C
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 12
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    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) No
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Canada
    Germany
    Netherlands
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    As per Protocol: The study will end when the last randomized patient completes 52 weeks of treatment (last patient last visit [LPLV] for last randomized patient).
    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 months1
    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 months4
    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: 780
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1453
    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 state123
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1465
    F.4.2.2In the whole clinical trial 2233
    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 Decision2016-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-21
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