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    Summary
    EudraCT Number:2021-005065-40
    Sponsor's Protocol Code Number:TA-8995-302
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-005065-40
    A.3Full title of the trial
    Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid Modifying Therapies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in patients with
    Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic
    Cardiovascular Disease (ASCVD, the narrowing of arteries from a buildup of plaque) whose current treatment with lipid-modifying therapies is not sufficiently effective.
    A.4.1Sponsor's protocol code numberTA-8995-302
    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 B.V.
    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 B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNewAmsterdam Pharma B.V.
    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 code1411 DC
    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 placeboTablet
    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
    dyslipidemia
    heterozygous familial hypercholesterolemia (HeFH)
    atherosclerotic cardiovascular disease (ASCVD)
    E.1.1.1Medical condition in easily understood language
    treatment of high cholesterol and 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020049
    E.1.2Term High cholesterol
    E.1.2System Organ Class 100000004848
    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.1.2 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 LDL-C levels at Day 84.
    E.2.2Secondary objectives of the trial
    -to evaluate the effect of obicetrapib on LDL-C levels at Days 180 and 365
    -to evaluate the effect of obicetrapib on ApoB, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), and triglycerides (TG) at Days 84, 180, and 365
    -to evaluate the effect of obicetrapib on lipoprotein (a) (Lp[a]) and apolipoprotein A1 (ApoA1) at Day 84
    -to evaluate the safety and tolerability profile of obicetrapib in a broadly representative population of adult males and females of all ages, including elderly and very elderly participants, assessed by AEs, events of special interest (ESIs), vital signs (including blood pressure), ECG measurements, and clinical laboratory values
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ABPM substudy
    This substudy is designed for a non-inferiority assessment in systolic blood pressure from Screening (Visit 1) to Day 270 (Visit 6) between obicetrapib and placebo.
    E.3Principal inclusion criteria
    1.Are willing and able to give written informed consent before initiation of any study-related procedures and willing to comply with all required study procedures;
    2.Are male or female ≥18 years of age at Screening (Visit 1);
    oFemales may be enrolled if all 3 of the following criteria are met:
    -They are not pregnant;
    -They are not breastfeeding; and
    -They do not plan on becoming pregnant during the study;
    oFemales of childbearing potential must have a negative urine pregnancy test at Screening (Visit 1);
    3.Have underlying HeFH and/or a history of ASCVD
    4.Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications defined as follows:
    -A statin at a maximally tolerated stable dose;
    -Ezetimibe for at least 8 weeks with or without maximally tolerated statin prior to Screening (Visit 1);
    -Bempedoic acid for at least 8 weeks in combination with a maximally tolerated statin prior to Screening (Visit 1); and/or
    -A proprotein convertase subtilisin/kexin type 9 (PCSK9)-targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening (Visit 1)

    Note: At least 70% of the participants enrolled into this study must be taking HISs. HISs include the following:
    -Atorvastatin 40 and 80 mg; and
    -Rosuvastatin 20 and 40 mg
    5.Have a fasting serum LDL-C as follows:
    o Have a fasting serum LDL-C ≥55 mg/dL (≥1.4 mmol/L) to <100 mg/dL (<2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to <130 mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers:
    -Recent MI (>3 and <12 months prior to Randomization);
    -Type 2 diabetes mellitus;
    - Current daily cigarette smoking;
    - Age of >60 years;
    - High sensitivity C-reactive protein (hsCRP) >=2.0 mg/L (>=19.0 nmol/L) at
    Screening (Visit 1) or within 6 months prior to Screening (Visit 1)
    -Fasting TG >150 mg/dL (>1.7 mmol/L);
    -Fasting Lp(a) >30 mg/dL (>70 nmol/L); and/or
    -Fasting HDL-C <40 mg/dL (<1.0 mmol/L); OR
    -Have a fasting serum LDL-C ≥100 mg/dL (≥2.6 mmol/L) OR non-HDL-C ≥130 mg/dL (≥3.4 mmol/L).;
    6. Have fasting TG <500 mg/dL (<5.7 mmol/L) at Screening; and
    7. Have an estimated glomerular filtration rate (eGFR) ≥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 (Visit 2) 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 x upper limit of normal (ULN); or total bilirubin >2 x ULN at Screening;
    7.Have HbA1c ≥10% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening (Visit 1);
    8.Have thyroid-stimulating hormone >1.5 x ULN at Screening (Visit 1);
    9.Have creatine kinase >3 x ULN at Screening (Visit 1);
    10.Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization (Visit 2);
    11.Have a known history of alcohol and/or drug abuse within 5 years prior to Randomization (Visit 2);
    12.Have received treatment with other investigational products or devices within 30 days of Screening (Visit 1) or 5 half lives of the previous investigational product, whichever is longer;
    13.Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1);
    14.Have planned use of other investigational products or devices during the course of the study;
    15.Have participated in any clinical study evaluating obicetrapib;
    16.Have a known allergy or hypersensitivity to the study drug, placebo, or any of the excipients in the study drug or placebo; or
    17.Have any participant condition that, according to the Investigator, could interfere with the conduct of the study, such as, but not limited to, the following:
    o Are unable to communicate or to cooperate with the Investigator;
    o Are unable to understand the protocol requirements, instructions and study-related restrictions, and the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency);
    o Are unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study);
    o Have any medical or surgical condition which, in the opinion of the Investigator, would put the participant at increased risk from participating in the study; or
    o Are directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    the percent change from Baseline to Day 84 in LDL-C in the obicetrapib group compared to the placebo group
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 84
    E.5.2Secondary end point(s)
    1. Percent change from Baseline to Days 180 and 365 in LDL-C in the obicetrapib group compared to the placebo group
    2.Percent change from Baseline to Days 84, 180 and 365 in ApoB in the obicetrapib group compared to the placebo group;
    3.Percent change from Baseline to Day 84, 180 and 365 in non-HDL-C in the obicetrapib group compared to the placebo group;
    4.Percent change from Baseline to Days 84, 180, and 365 in HDL-C in the obicetrapib group compared to the placebo group;
    5.Percent change from Baseline to Day 84 in Lp(a) and ApoA1 in the obicetrapib group compared to the placebo group;
    6.Percent change from Baseline to Days 84, 180, and 365 in fasting TC in the obicetrapib group compared to the placebo group; and
    7.Percent change from Baseline to Days 84, 180, and 365 in fasting TG in the obicetrapib group compared to the placebo group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, 180, 365
    2,3,4,6,7) Baseline, Day 84, 180, 365
    5) Baseline, Day 84
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    China
    Czechia
    Denmark
    Georgia
    Japan
    Netherlands
    Poland
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days18
    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: 2080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 520
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2600
    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 Decision2022-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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