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    Summary
    EudraCT Number:2018-001949-13
    Sponsor's Protocol Code Number:LIRHV
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-001949-13
    A.3Full title of the trial
    The effect of liraglutide on MMC activity, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of a gastrointestinal hormone (GLP-1)agonist on gastrointestinal contractility during the fasted state, gastrointestinal hormones, hunger ratings and ad libitum food intake in healthy volunteers
    A.3.2Name or abbreviated title of the trial where available
    LIRHV
    A.4.1Sponsor's protocol code numberLIRHV
    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 SponsorKU Leuven
    B.1.3.4CountryBelgium
    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 supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointClinical Trials into TARGID
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49 - box 701
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3201637 37 65
    B.5.6E-mailwout.verbeure@kuleuven.be
    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 Yes
    D.2.1.1.1Trade name Victoza
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLiraglutide
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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/infusion
    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
    The study will focus on the underlying mechanisms of obesity.
    The effects will first be investigated in healthy, lean volunteers.
    E.1.1.1Medical condition in easily understood language
    The study will focus on the underlying mechanisms of obesity.
    The effects will first be investigated in healthy, lean volunteers.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    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 detect changes in MMC activity after administration of liraglutide compared to placebo.
    E.2.2Secondary objectives of the trial
    1) To detect changes in the release of gastrointestinal hormones after liraglutide compared to placebo.
    2) To detect changes in hunger after liraglutide compared to placebo.
    3) To detect changes in ad libitum food intake after liraglutide compared to placebo.
    4) To detect changes in blood glucose levels after liraglutide compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is female or male between 18 and 65 years of age.
    Subject has a BMI between 18 and 25 kg/m² and has a stable body weight for at least 3 consecutive months at the start of the study and keeps a stable weight during the study visits.
    Women of child-bearing potential agree to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
    Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
    E.4Principal exclusion criteria
    Subject is under age of legal consent, pregnant or breastfeeding.
    Subject with a BMI ≤ 18 kg/m² or BMI ≥ 25 kg/m².
    Subject has current symptoms or a history of gastrointestinal or other significant somatic or psychiatric diseases or drug allergies.
    Subject has diabetes.
    Subject has a significant heart, lung, liver or kidney disease.
    Subject has any history of a neurological disorder.
    Subject has a history of abdominal surgery. Those having undergone a simple appendectomy more than 1 year prior to the screening visit may participate.
    Subject shows abnormal eating behavior or has an eating disorder.
    History or current use of drugs that can affect glycaemia, gastrointestinal function, motility or sensitivity or gastric acidity.
    History or current use of centrally acting medication, including antidepressants, antipsychotics and/or benzodiazepines (in the last year before screening visit).
    Subject consumes excessive amounts of alcohol, defined as >14 units per week for women and >21 units per week for men.
    Subject is currently (defined as within approximately 1 year of the screening visit) a regular or irregular user (including “recreational use”) of any illicit drugs (including marijuana) or has a history of drug (including alcohol) abuse. Further, patient is unwilling to refrain from the use of drugs during this study.
    High caffeine intake (> 500 ml coffee daily or equivalent).
    Inability or unwillingness to perform all of the study procedures, or the subject is considered unsuitable in any way by the principal investigator.
    Recent participation (<30 days) or simultaneous participation in another clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    MMC activity compared between placebo and treatment with liraglutide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The volunteers have 10 visits in total for this study, for each condition 5 consecutive days.
    At day 4 and 9 (the cross-over of conditions), the MMC is continuously measured, starting at 7 am until 1 pm.
    E.5.2Secondary end point(s)
    - Gastrointestinal hormone release compared between placebo and treatment with liraglutide
    - Hunger sensations compared between placebo and treatment with liraglutide
    - Ad libitum food intake compared between placebo and treatment with liraglutide
    - Glucose whole blood levels compared between placebo and treatment with liraglutide
    E.5.2.1Timepoint(s) of evaluation of this end point
    The volunteers have 10 visits in total for this study, for each treatment arm 5 consecutive days.

    Blood samples will be measured at days: 4, 5, 9 and 10. A first blood sample is taken prior to the treatment (placebo or liraglutide).
    For day 4 and 9 after the injection, blood samples are collected every 30 min until 1 pm.
    For day 5 and 10 after the injection, blood samples are collected every 30 min until 1.30 pm and one more sample at 3 pm after the ad libitum buffet.

    Hunger, prospective food consumption and satiety will be scored every 5 min and hunger related symptoms will be scored on VAS of 100 mm every 30 min from the start of the study until the end of the study on days 4, 5, 9 and 10.

    On day 5 and 10, the volunteers eat ad libitum from a free choice buffet.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    The weight loss effect of liraglutide is already known, but not all mechanisms of action are clear.
    This study will cover physiological effects which affect food consumption (MMC, gastrointestinal hormones, hunger feelings, ...) and test if liraglutide effects food consumption by these variables.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state15
    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 Decision2019-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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