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    Summary
    EudraCT Number:2021-003168-28
    Sponsor's Protocol Code Number:77458
    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:2022-04-02
    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 number2021-003168-28
    A.3Full title of the trial
    Impact of Triglyceride-Lowering on Inflammatory Activity in Patients with Hypertriglyceridemia
    Effect van triglyceride verlaging op inflammatoire activiteit in patienten met hypertriglyceridemie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact on inflammation in lowering levels of triglycerides in patients
    Effect van ontsteking bij het verlagen van triglyceride waardes in patienten
    A.4.1Sponsor's protocol code number77458
    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 SponsorAcademic Medical Center (AMC), department of Internal Medicine
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAcademic Medical Center (AMC), department of Internal Medicine
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center (AMC)
    B.5.2Functional name of contact pointDepartment of Internal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-maile.s.stroes@amsterdamumc.nl
    D. IMP Identification
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Hypertriglyceridemia
    - Inflammation
    - Lipoproteins
    - Hypertriglyceridemie
    - Inflammatie
    - Lipoproteinen
    E.1.1.1Medical condition in easily understood language
    - Elevated levels of triglycerides
    - Inflammation
    - Cholesterol
    - Verhoogde waardes van triglycerides
    - Ontsteking
    - Cholesterol
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the impact of AKCEA-APOCIII-LRx on lipid and inflammatory measurements in the fasting and postprandial phase.
    Het onderzoeken van de impact van AKCEA-APOCIII-LRx op lipide en inflammatoire parameters in zowel de nuchtere als postprandiale fase.
    E.2.2Secondary objectives of the trial
    Study the impact of AKCEA-APOCIII-LRx on 15 expression markers on monocyte phenotyping using mass cytometry.
    et onderzoeken van de impact van AKCEA-APOCIII-LRx op 15 expressie markers in monocyte fenotypering met behulp van massa cytometry.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults above 18 years old
    - Triglyceride levels > 4mmol/l (350 mg/dl)
    - Volwassenen van 18 jaar en ouder
    - Triglyceride waardes > 4 mmol/l (350 mg/dl)
    E.4Principal exclusion criteria
    - Molecularly diagnosed familial chylomicronemia syndrome (homozygous and/or compound heterozygous)
    - Use of fibrates or fish oil: both have to be discontinued for at least 4 weeks prior to baseline visit
    - Uncontrolled diabetes (HBa1C > 70 mmol/mol)
    - Alcohol intake > 4c/day
    - ASAT/ALAT > 3x ULN
    - Renal insufficiency, defined as eGFR < 30 ml/min
    - Platelet count < 150.000 and > 450.000 /mm3
    - Pancreatitis < 8 weeks prior to baseline visit
    - Body mass index (BMI) > 35.0 kg/m2
    - Premenopausal women not using birth-control
    - Uncontrolled hypertension (systolic > 180 mmHg; diastolic > 105 mmHg)
    - Diagnosis of (active) malignancy in last 5 years
    - Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
    - Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
    - Moleculair gediagnosticeerde familiar chylomicronemie syndroom (homozygoot en/of compound heterozygoot)
    - Gebruik van fibraten of visolie: beiden moeten ten minste 4 weken voor de baseline visit gestopt zijn.
    - Ongecontroleerde diabetes (HBa1C > 70 mmol/mol)
    - Alcohol inname > 4 EH /dag
    - ASAT/ALAT > 3x ULN
    - Nierinsufficientie, gedefinieerd als eGFR < 30 ml/min
    - Bloedplaatjes < 150.000 en > 450.000 /mm3
    - Pancreatitis < 8 weken voor de baseline visit
    - Body mass index (BMI) > 35 kg/m2
    - Premenopauzale vrouwen zonder anticonceptie
    - Ongecontroleerde hypertensie (systolisch > 180 mmHg; diastolisch > 105 mmHg)
    - Diagnose van (actieve) maligniteit in de laatste 5 jaar
    - Een andere behandeling of klinisch relevante aandoening dat kan interfereren met het uitvoeren of interpretatie van de studie in de opinie van de onderzoeker
    - Onmogelijkheid of onbereidheid te voldoen aan het protocol, of door de onderzoeker geacht ongeschikt te zijn voor de studie
    E.5 End points
    E.5.1Primary end point(s)
    - The mean percentage change in fasting apoC-III and triglyceride reduction between the treatment and placebo group, at the primary analysis time point, compared to baseline.
    - Postprandial TG (AUC) change at the primary analysis time point from baseline as compared to placebo.
    - De gemiddelde percentage verandering in nuchtere apo-CIII en triglyceride verlaging tussen de behandel en placebo groep, op het primaire analyse tijdpunt in vergelijking met baseline.
    - Postprandiale triglyceriden (AUC) verandering op het primaire analyse tijdpunt van baseline in vergelijking met placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis time point is at 7 weeks.
    De primaire analyse tijdpunt is op 7 weken.
    E.5.2Secondary end point(s)
    The secondary outcome is:
    • Mass cytometry: whole-blood with 15 marker panel for monocyte phenotyping; expression markers such as CD14 and CD16

    Exploratory study parameters/endpoints
    • The mean percentage change of the following parameters between the treatment and placebo group, at the primary analysis time point, compared to baseline:
    o Lipid parameters: LDL-C, HDL-C, VLDL-C, TC, (non-HDL-C), apoA-I, apoB, apoB48, Lp(a), remnant cholesterol (RC) (by a deika-senken assay)
    o Inflammatory parameters: hsCRP, IL-6, Il-1beta, IL-10, IL-18, E-selectin, P-selectin, soluble ICAM, soluble VCAM, von Willebrand factor
    • CD14-bead isolation of monocytes for:
    o Lipid droplets, lipid size with Nile Red Quantifier (NRQ)
    • Kinetic monocyte transendothelial migration (TEM) assay in the fasting and postprandial phase, comparing the treatment with the placebo group
    • Extracellular vesicle count and composition
    De secundaire uitkomstmaat is:
    - Mass cytometrie: 15 marker panel voor monocyten fenotypering; expressie markers zoals CD14 en CD16

    Exploratieve studie parameters zijn:
    - De gemiddelde percentage verandering tussen de behandeling en placebo groep, op het primaire analyse eindpunt vergeleken met baseline van:
    - Lipide metingen: LDL-C, HDL-C, VLDL-C, TC, fasting TG, (non-HDL-C), apoA-I, apoB, apoB48, ApoC-III, Lp(a), remnant cholesterol (RC) (by a deika-senken assay)
    - Inflammatoire metingen: CRP, IL-6, IL-1b, IL-10, IL-18, E-selectine, P-selectine, soluble ICAM, soluble VCAM, von Willebrand factor
    - Kinetic monocyte transendothelial migration assay
    - CD14-bead isolatie van monocyten voor lipid droplets en lipid size
    - Extracellular vesicle count en composition
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis time point is at 7 weeks.
    De primaire analyse tijdpunt is op 7 weken.
    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 No
    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.6.13.1Other scope of the trial description
    na
    Nvt
    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 No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state30
    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)
    Regular treatment will be continued as primary cardiovascular disease and/or pancreatitis prevention in patients with elevated triglyceride levels.
    In het kader van primaire preventie van het cardiovasculair risico en/of pancreatitis bij patiënten met verhoogde triglyceridewaardes wordt de standaard behandeling voortgezet.
    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 Decision2022-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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