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    Summary
    EudraCT Number:2021-005092-39
    Sponsor's Protocol Code Number:TA-8995-304
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-07
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-005092-39
    A.3Full title of the trial
    Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo-Controlled Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Whose Current Treatment with Lipid-Modifying Therapies is not Sufficiently Effective.
    A.4.1Sponsor's protocol code numberTA-8995-304
    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 SponsorNewAmsterdam Pharma BV
    B.1.3.4CountryNetherlands
    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 supportNewAmsterdam Pharma BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewAmsterdam Pharma BV
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressGooimeer 2-35
    B.5.3.2Town/ cityNaarden
    B.5.3.3Post codeGooimeer 2-35
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 35 2062971
    B.5.5Fax number+31 35 2062971
    B.5.6E-mailmarc.ditmarsch@newamsterdampharma.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 nameobicetrapib
    D.3.2Product code TA-8995
    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 INNOBICETRAPIB
    D.3.9.1CAS number 866399-89-5
    D.3.9.2Current sponsor codeTA-8995
    D.3.9.4EV Substance CodeSUB188624
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    atherosclerotic cardiovascular disease (ASCVD)
    E.1.1.1Medical condition in easily understood language
    atherosclerotic heart and blood vessel disease (the narrowing of arteries from a buildup of plaque)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 26.0
    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 10076622
    E.1.2Term Atherosclerotic plaque
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of obicetrapib on the risk of major adverse CV events (MACE), including CV death, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization.
    E.2.2Secondary objectives of the trial
    • CV death, non-fatal MI, or non-fatal stroke;
    • All-cause mortality, non-fatal MI, non-fatal stroke, or non-elective coronary revascularization;
    • Any individual component of the primary composite endpoint;
    • Total CV events;
    • All-cause mortality;
    • New-onset diabetes mellitus (NODM);
    • Percent change in low-density lipoprotein cholesterol (LDL-C);
    • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C);
    • Percent change in apolipoprotein B (ApoB); and
    • Absolute change in glycosylated hemoglobin (HbA1c) in participants with diabetes mellitus and HbA1c ≥7% at Baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female and ≥18 years of age at Screening (Visit 1);
    - Have a history of ASCVD, defined by at least 1 of the following conditions:
    o Coronary artery disease
    o Cerebrovascular disease
    o Peripheral arterial disease
    - Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid lowering diet and other lifestyle modifications, defined as follows:
    o A statin at a maximally tolerated stable dose;
    o Ezetimibe for at least 8 weeks with or without a maximally tolerated statin prior to Screening (Visit 1);
    o Bempedoic acid for at least 8 weeks in combination with a maximally tolerated statin prior to Screening (Visit 1); and/or
    o A PCSK9-targeted therapy alone or in combination with other lipidmodifying therapy for at least 4 stable doses prior to Screening (Visit 1);
    o At least 70% of the participants enrolled into this study must be taking HISs. Documentation in the eCRF of the reason why a participant is unable to take HISs is required. HISs include the following:
    o Atorvastatin 40 and 80 mg; and
    o Rosuvastatin 20 and 40 mg
    - Have a fasting serum LDL-C at Screening (Visit 1) as follows:
    o Have a fasting serum LDL-C ≥70 mg/dL to <100 mg/dL with at least 1 of the following risk enhancers:
    - Recent MI (>3 and <12 months prior to Randomization);
    - Type 2 diabetes mellitus;
    - Fasting triglycerides (TG) >150 mg/dL (>1.7 mmol/L); and/or
    - Fasting high density lipoprotein cholesterol <40 mg/dL (<1.0
    mmol/L).
    OR
    o Have a fasting serum LDL-C ≥100 mg/dL.
    - Have fasting TG <400 mg/dL (<4.52 mmol/L) at Screening (Visit 1);
    and
    - Have an estimated glomerular filtration rate ≥30 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
    Other protocol-defined criteria apply.
    E.4Principal exclusion criteria
    1. Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
    2. Have been hospitalized for HF within 5 years prior to Screening (Visit 1);
    3. Have had any of the following clinical events within 3 months prior to Screening (Visit 1):
    o Non-fatal MI;
    o Non-fatal stroke;
    o Non-elective coronary revascularization; and/or
    o Hospitalization for unstable angina and/or chest pain;
    4. Have uncontrolled severe hypertension, defined as either systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization, taken as the average of triplicate measurements. One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized;
    5. Have a formal diagnosis of homozygous familial hypercholesterolemia;
    6. Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1);
    7. Have an HbA1c ≥10.0% or a fasting glucose ≥270 mg/dL at Screening (Visit 1);
    8. Have a thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1);
    9. Have a creatine kinase >3 × ULN at Screening (Visit 1);
    10. Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1).
    Other protocol-defined criteria apply.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY

    1) the time from Randomization to the first confirmed occurrence of any component of the composite endpoint, including the following:
    - CV death;
    - Non-fatal MI;
    - Non-fatal stroke; or
    - Non-elective coronary revascularization.

    SAFETY

    2) AEs and events of special interest (ESIs);
    3) Vital signs (including blood pressure);
    4) Electrocardiograms; and
    5) Clinical laboratory assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline to EOS
    2) V1 to EOT and EOS
    3) V1, V2, V4, V5, V6+Q6M, EOT
    4) Visit 2, EOT
    5) V1, V2, V4, V5, V6+Q6M, EOT
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints, in hierarchical order, include the following:
    1) The time from Randomization until the first confirmed occurrence of a composite of CV death, non-fatal MI, or non-fatal stroke;
    2) The time from Randomization until the first confirmed occurrence of a composite of all-cause mortality, non-fatal MI, non-fatal stroke, or nonelective coronary revascularization;
    3) A total event analysis, defined as the number of CV death events, and first and subsequent/recurrent events of non-fatal MIs, non-fatal strokes, and non-elective coronary revascularization from Randomization until the EOS Visit;
    4) The time from Randomization until the first confirmed occurrence of non-fatal MI;
    5) The time from Randomization until the first confirmed occurrence of non-elective coronary revascularization;
    6) The time from Randomization until the confirmed occurrence of CV death;
    7) The time from Randomization until the first confirmed occurrence of non-fatal stroke;
    8) The time from Randomization until the confirmed occurrence of all cause mortality;
    9) The time from Randomization until the first confirmed occurrence of NODM;
    10) Percent change in LDL-C from Baseline to Day 365 and to the EOT Visit;
    11) Percent change in non-HDL-C from Baseline to Day 365 and to the EOT Visit;
    12) Percent change in ApoB from Baseline to Day 365; and
    13) Percent change in HbA1c in participants with diabetes mellitus and HbA1c ≥7% at Baseline, from Baseline to Day 365 and to the EOT Visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3,4,5,6,8) Baseline to EOS
    7) EOS
    9,10,12) Baseline, Day 365/EOT
    11) Baseline to Day 365
    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 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 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) 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 concerned33
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Australia
    Canada
    China
    Israel
    Japan
    Jordan
    South Africa
    United States
    European Union
    Georgia
    Croatia
    Finland
    United Kingdom
    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
    LSLV (The DSMB will review 1 interim analysis during the study after
    approximately 671 events have been adjudicated, corresponding to
    approximately 70% of the planned total number of events for the
    study. After this interim analysis, the DSMB may recommend that the
    study is stopped for overwhelming efficacy, or safety concerns).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 4050
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4950
    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 state624
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4857
    F.4.2.2In the whole clinical trial 9000
    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)
    standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Vascular Research Network (VRN)
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation WCN
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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