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    Summary
    EudraCT Number:2020-005845-18
    Sponsor's Protocol Code Number:D7990C00004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005845-18
    A.3Full title of the trial
    A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia
    Estudio Fase 2b, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de AZD8233 en pacientes con hiperlipidemia (SOLANO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants with Hyperlipidaemia
    Estudio de fase IIb para evaluar la seguridad, la eficacia y la tolerabilidad del tratamiento con AZD8233 en participantes con hiperlipidemia
    A.3.2Name or abbreviated title of the trial where available
    SOLANO
    A.4.1Sponsor's protocol code numberD7990C00004
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900 200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.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 nameAZD8233 solution for injection
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAZD8233
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperlipidaemia, evaluation of low-density lipoprotein cholesterol reduction and safety of AZD8233 vs. placebo
    Hiperlipidemia, evaluación de la reducción del colesterol de lipoproteínas de baja densidad y seguridad de AZD8233 versus placebo.
    E.1.1.1Medical condition in easily understood language
    Hyperlipidaemia is an abnormal level of lipids (fats) in the blood
    Hiperlipidemia es un nivel anormal de lípidos en sangre
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062060
    E.1.2Term Hyperlipidaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of AZD8233 as compared with placebo in participants with hyperlipidaemia receiving maximally tolerated statin and/or ezetimibe therapy as defined by the investigator
    • To assess the effect of AZD8233 versus placebo on serum LDL-C at the end of Week 28 compared with baseline, in participants with hyperlipidaemia, receiving maximally tolerated statin and/or ezetimibe therapy as defined by the investigator
    • Evaluar la seguridad y la tolerabilidad de AZD8233 en comparación con placebo en participantes con hiperlipidemia que reciben tratamiento con estatinas y/o ezetimiba a las dosis máximas toleradas, según lo determinado por el investigador
    • Evaluar el efecto de AZD8233 en comparación con placebo en el c-LDL sérico al final de la semana 28 en comparación con el inicio en participantes con hiperlipidemia que reciben tratamiento con estatinas y/o ezetimiba a las dosis máximas toleradas, según lo determinado por el investigador
    E.2.2Secondary objectives of the trial
    -To assess the effect of AZD8233 versus placebo on plasma PCSK9 at the end of Week 28 compared with baseline, in participants with hyperlipidaemia, receiving maximally tolerated statin and/or ezetimibe therapy as defined by the investigator
    - To evaluate the PK of AZD8233
    - To evaluate the immunogenicity of AZD8233
    • Evaluar el efecto de AZD8233 en comparación con placebo en la PCSK9 plasmática al final de la semana 28 en comparación con el inicio en participantes con hiperlipidemia que reciben tratamiento con estatinas y/o ezetimiba a las dosis máximas toleradas, según lo determinado por el investigador
    • Evaluar la FC de AZD8233
    • Evaluar la inmunogenicidad de AZD8233
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be 18 to 75 years of age, inclusive, at the time of signing the informed consent
    -Participants who have a fasting LDL-C ≥ 70 mg/dL (1.8 mmol/L) but < 190 mg/dL (4.9 mmol/L) at screening
    -Participants who have fasting triglycerides < 400 mg/dL (< 4.52 mmol/L) at screening
    -Participants are receiving a stable dose (≥ 3 months) of maximally tolerated statin and/or ezetimibe therapy
    -Male or female of non-childbearing potential
    -Signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses
    - Los participantes deben tener entre 18 y 75 años de edad, inclusive, en el momento de firmar el formulario de consentimiento informado
    - Participantes que en la selección presenten un c-LDL en ayunas ≥ 70 mg/dl (1,8 mmol/l) pero <190 mg/dl (4,9 mmol/l).
    - Participantes que en la selección presenten una cifra de triglicéridos en ayunas <400 mg/dl (<4,52 mmol/l).
    - Los participantes que estén recibiendo una dosis estable (desde hace ≥3 meses) de tratamiento con estatinas y/o ezetimiba a las dosis máximas toleradas.
    - Hombres o mujeres que no puedan concebir.
    - Consentimiento firmado y fechado antes de cualquier procedimiento del estudio, extracciones de muestras y análisis.
    E.4Principal exclusion criteria
    - eGFR < 40 mL/min/1.73m2 using the CKD-EPI
    - History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs
    - Any uncontrolled or serious disease, or any medical (eg,. known major active infection or major haematological, renal, metabolic, gastrointestinal or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk (according to the investigator’s judgment) if he/she participates in the clinical study
    - Poorly controlled T2DM, defined as HbA1c > 10%
    - Acute ischaemic cardiovascular events including stroke within 30 days, or heart failure with New York Heart Association (NYHA) Class III to IV
    - Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds)
    - High-risk of bleeding diathesis or anti-platelet therapy other than low dose aspirin (≤100mg/day).
    - Malignancy within the last 10 years
    - Recipient of any major organ transplant
    - LDL or plasma apheresis within 12 months prior to randomisation
    - Uncontrolled hypertension defined as average supine SBP > 160 mmHg or DBP > 90 mmHg
    - Heart rate after 10 minutes supine rest < 50 or > 100 bpm
    - Any laboratory values with the following deviations at the Screening Visit; test may be repeated at the discretion of the investigator if abnormal:
    • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
    • ALT > 1.5 × ULN
    • AST > 1.5 × ULN
    • TBL > ULN
    • ALP > 1.5 × ULN
    • WBC < lower limit of normal (LLN).
    • Haemoglobin < 12 g/dL in males or < 11 g/dL in females
    • Platelet count ≤ LLN
    • aPTT > ULN or Prothrombin Time > ULN
    • UACR > 11 mg/mmol (100 mg/g)
    • UPCR > 300 mg/g

    -Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
    -QTcF > 470 ms; high degree atrioventricular (AV)-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias
    -History of drug and/or alcohol abuse or a positive screen for drugs of abuse
    -use of warfarin, direct or indirect thrombin inhibitors or factor Xa inhibitors
    -Mipomersen, or lomitapide within 12 months prior to randomisation
    -Any fibrate therapy other than fenofibrate; if the participant is on fenofibrate therapy, the dose should be stable for at least 6 weeks prior to randomisation
    -Previous administration of AZD8233/AZD6615) or inclisiran (LEQVIO ® Novartis)
    -Use of evolocumab (REPATHA® Amgen) and alirocumab (PRALUENT® Regeneron) within 3 months of screening
    - eGFR <40 ml/min/1,73 m2 mediante ERC-EPI.
    - Antecedentes o presencia de enfermedad gastrointestinal, hepática o renal, o cualquier otra afección que se sepa que interfiere con la absorción, la distribución, el metabolismo o la excreción de fármacos.
    - Cualquier enfermedad no controlada o grave, o cualquier afección médica (p. ej., infección activa importante conocida o disfunción hematológica, renal, metabólica, gastrointestinal o endocrina importante) o quirúrgica que, en opinión del investigador, pueda interferir con la participación en el estudio clínico y/o someter a la persona a un riesgo considerable (a juicio del investigador) si participa en el ensayo clínico.
    - DMT2 mal regulada, definida como HbA1c >10 %.
    - Acontecimiento cardiovascular isquémico agudo, incluyendo ictus, en los 30 días anteriores o insuficiencia cardíaca de clase III o IV según la Asociación de Cardiología de Nueva York (NYHA).
    - Discrasias sanguíneas con aumento del riesgo de hemorragia, incluidas la púrpura trombocitopénica idiopática y la púrpura trombocitopénica trombótica, o síntomas de aumento del riesgo de hemorragia (hemorragia gingival o nasal frecuente).
    - Alto riesgo de diátesis hemorrágica o algún tratamiento antiplaquetario diferente a aspirina en dosis bajas (≤100mg/día).
    - Neoplasia maligna en los últimos 10 años.
    - Receptor de algún trasplante de órgano importante.
    - Aféresis de LDL o plasmaféresis en los 12 meses anteriores a la aleatorización.
    - Hipertensión no controlada definida como presión arterial sistólica (PAS) media >160 mmHg o presión arterial diastólica (PAD) >90 mmHg.
    - Frecuencia cardíaca <50 lpm o >100 lpm después de 10 minutos en reposo.
    - Cualquier valor analítico que presente las siguientes desviaciones en la visita de selección; la prueba puede repetirse a discreción del investigador si es anómala:
    • Cualquier resultado positivo en la selección para el antígeno de superficie de la hepatitis B, anticuerpos contra la hepatitis C y el virus de la inmunodeficiencia humana (VIH) en suero.
    • ALT >1,5 × LSN.
    • AST >1,5 × LSN.
    • Bilirrubina total (BT) >LSN.
    • Alcalina fosfatasa (AF) >1,5 × LSN.
    • Leucocitos (LEU) < LIN.
    • Hemoglobina <12 g/dl en hombres o <11 g/dl en mujeres.
    • Recuento plaquetario ≤LIN.
    • TTPa >LSN o tiempo de protrombina >LSN.
    • UACR >11 mg/mmol (100 mg/g).
    • UPCR >300 mg/g.
    - Cualquier anomalía clínicamente importante en el ritmo, la conducción o la morfología del ECG en reposo y cualquier anomalía clínicamente importante en el ECG de 12 derivaciones.
    - Intervalo QT corregido según la fórmula de Fridericia (QTcF) >470 ms; alto grado de bloqueo auriculoventricular (AV), de grado II-III, y disfunción de los nódulos sinusales con pausa sinusal significativa sin tratamiento con marcapasos; y taquiarritmias cardiacas.
    - Antecedentes conocidos de drogadicción o sospecha de ello, o confirmación de abuso de drogas en la visita de selección.
    - Uso de Warfarina, inhibidores directos o indirectos de la trombina o inhibidores del factor Xa.
    - Mipomersén o lomitapida en los 12 meses anteriores a la aleatorización.
    - Cualquier tratamiento con fibratos que no sean fenofibrato; si el participante está en tratamiento con fenofibrato, la dosis debe permanecer estable durante al menos 6 semanas antes de la aleatorización.
    - Administración previa de AZD8233/AZD6615 o inclisirán (LEQVIO ®, Novartis).
    - Uso de evolocumab (REPATHA®, Amgen) y alirocumab (PRALUENT®, Regeneron) en los 3 meses anteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
     Safety and tolerability will be evaluated in terms of AEs, vital signs, ECG, and clinical laboratory
    evaluations, including platelet count
     The relative change in serum LDL-C from baseline to the end of Week 28
    La seguridad y la tolerabilidad se evaluarán en términos de AA, constantes vitales, ECG y evaluaciones analíticas clínicas, incluido el recuento plaquetario
    El cambio relativo en el c-LDL sérico desde el inicio hasta el final de la semana 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    safety and tolerability: throughout the study
    efficacy: D197
    seguridad y tolerabilidad: mediante el estudio
    eficacia: D197
    E.5.2Secondary end point(s)
    • The relative change in PCSK9 from baseline to the end of Week 28
    • Model population PK parameters to be reported in a separate report
    • Development of ADA and titre (if participants are ADA positive) during treatment and follow-up
    • El cambio relativo en la PCSK9 desde el inicio hasta el final de la semana 28
    • Parámetros FC de la población modelo para notificarlo en un informe por separado
    • Desarrollo de AAF y concentraciones (si los participantes arrojan un resultado positivo para AAF) durante el tratamiento y el seguimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSCK9: D197
    PK: D29, D85, D99, D141, D197
    ADA: D1, D29, D57, D85, D113, D141, D169, D197, D281
    PSCK9: D197
    PK: D29, D85, D99, D141, D197
    ADA: D1, D29, D57, D85, D113, D141, D169, D197, D281
    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 No
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity:Blood samples collection for immunogenicity assessments (ADA).

    Exploratory biomarkers analysis: Blood and urine samples collection for potential future exploratory research aimed at exploring biomarkers involved in PK, PD, safety and tolerability related to AZD8233 treatment or cardiometabolic diseases.

    Optional: DNA storage from blood samples for future exploratory research into genes/genetic variation that may influence response to treatment.
    Inmunogenicidad: evaluación de anticuerpos antifármaco en sangre.

    Análisis exploratorio de biomarcadores: muestras de sangre y orina para investigar biomarcadores implicados en la farmacocinética, farmacodinámica, seguridad y tolerabilidad asociada al tratamiento con AZD8233 o enfermedades cardiacas.

    Opcional: Almacenamiento de ADN de muestras de sangre para investigaciones futuras exploratorias de genes/ variación genética que pueden influir en la respuesta a tratamiento.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    United States
    Denmark
    Hungary
    Netherlands
    Poland
    Slovakia
    Spain
    Czechia
    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
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days26
    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: 251
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 336
    F.4.2.2In the whole clinical trial 376
    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
    Ninguno
    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 Decision2021-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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