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    Summary
    EudraCT Number:2020-000548-71
    Sponsor's Protocol Code Number:NOK0020
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-12-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000548-71
    A.3Full title of the trial
    Liraglutide for low-responders after bariatric surgery
    Liraglutide voor patiënten die na bariatrische chirurgie minder afvallen dan verwacht.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liraglutide for patients who have undergone bariatric surgery and do not achieve sufficient weight loss.
    Liraglutide voor patiënten die na een maagverkleinende operatie minder afvallen dan verwacht.
    A.3.2Name or abbreviated title of the trial where available
    LIBAR
    LIBAR
    A.4.1Sponsor's protocol code numberNOK0020
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1227-6173
    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 SponsorNederlandse Obesitas Kliniek
    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 supportNederlandse Obesitas Kliniek
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNovo Nordisk
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNederlandse Obesitas Kliniek
    B.5.2Functional name of contact pointValerie Monpellier
    B.5.3 Address:
    B.5.3.1Street Addressamersfoortseweg 43
    B.5.3.2Town/ cityhuis ter heide
    B.5.3.3Post code3712 BA
    B.5.3.4CountryNetherlands
    B.5.6E-mailvmonpellier@obesitaskliniek.nl
    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 Saxenda
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Suspension 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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Morbid obesity
    Morbide obesitas
    E.1.1.1Medical condition in easily understood language
    Morbid obesity
    Morbide obesitas
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in patients who are low responders 3 months after bariatric surgery.
    Het doel van dit onderzoek is het effect van Liragltuide (3.0mg/dag) op gewichtsverlies 9 maanden na operatie te bestuderen bij patiënten die 3 maanden na bariatrische chirurgie een slechte respons qua gewichtsverlies hebben.
    E.2.2Secondary objectives of the trial
    There are three secondary objectives:
    a) To describe the persistence of therapy and the average daily dose patients used
    b) To describe the gastro-intestinal symptoms and eating habits of the study group
    c) To study the weight loss at 12, 18, 24 and 36 months after surgery
    Er zijn 3 secundaire doelen:
    a) onderzoeken hoe veel mensen tot het eind de medicatie gebruiken en wat de gemiddelde dagelijkse doses was
    b) de gastro-intestinale symptomen en eet gewoontes te beschrijven in de studie groep
    c) het gewichtsverlies 12, 18 , 24 en 36 maanden na operatie te bestuderen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient is ≥18 and <75 years old
    • BMI before surgery was ≥ 35 kg/m2
    • Patient is treated with group consultation at the NOK
    • Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
    • Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
    • leeftijd ≥18 en <75 jaar
    • BMI voor bariatrische chirurgie ≥ 35.0 kg/m2
    • patient volgt groepstraject bij de Nederlande Obesitas Kliniek
    • patiënt heeft een primaire Roux-en-Y gastric bypass (RYGB) of sleeve gastrectomie (SG) ondergaan
    • gewichtsverlies van de patiënt 3 maanden na operatie is in het laagste kwartiel en patiënt zal hiervoor behandeld worden in de plusmodule.
    E.4Principal exclusion criteria
    • Type 1 or type 2 diabetes
    • Decreased renal function (creatinine clearance < 30 ml/min)
    • Liver failure (all)
    • Congestive heart failure or angina pectoris NYHA class III and IV
    • Malignancy in history
    • Pancreatitis (in history)
    • Pregnancy / breast-feeding
    • Inflammatory Bowel Disease
    • Thyroid malignancy in history
    • Use of warfarin or other coumarin derivates
    • Type 1 of type 2 diabetes
    • Verminderde nierfunctie (creatinine klaring < 30 ml/min)
    • Leverfalen
    • Congestief hart falen of angina pectoris (NYHA klasse III en IV)
    • Maligniteit in voorgeschiedenis
    • Pancreatitis (in voorgeschiedenis)
    • Zwangerschap/borstvoeding
    • Inflammatoire darm ziekte
    • Schildklier maligniteit in voorgeschiedenis
    • Gebruik van warfarine of andere coumarine derivaten
    E.5 End points
    E.5.1Primary end point(s)
    %TWL at 9 months after surgery.
    % TWL 9 maanden na operatie
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months after surgery.
    9 maanden na operatie
    E.5.2Secondary end point(s)
    Secondary endpoints will include medication use:
    - Number and percentage of patients in whom dose escalation was according to protocol
    - Number and percentage of patients who used 3.0 mg as a daily dose for 22 weeks
    - Average daily dose of all patients (after the dose escalation)

    Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the “eating habits and physical problems” scales of the BODY-Q questionnaire which will be administered at study start and at 14 weeks after study start.

    Weight loss (%TWL) at longer follow-up will also be studied. For this study we will collect measurements at the following moments: 12-, 18-, 24-, and 36-months after surgery.
    Het eerste secundaire eindpunt is medicatie gebruik, de volgende zaken zullen geëvalueerd worden:
    - aantal en percentage patiënten die volgens protocol behandeld is
    - aantal en percentage patiënte die 3.0 mg liraglutide 22 weken heeft gebruikt
    - gemiddelde dagelijkse dosis die patiënten hebben gebruikt (na opbouwschema)

    Het 2e secundaire eindpunt zijn gastro-intestinale symptomen en eetgedrag. dit wordt gerapporteerd via de " adverse events" rapportage en doordat patiënten bij studie start en na 14 weken een vragenlijst hierover zullen invullen. Dit betreft de schalen eetgedrag en fysieke problemen van de BODY-Q.

    Het 3e secundaire eindpunt is gewichtsverlies op lange termijn, dat wil zeggen 12, 18, 24 en 36 maanden na operatie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Medication use: during whole treatment program
    Questionnaire: start of study and 14 weeks after start
    TWL: 12-, 18-, 24-, and 36-months after surgery.
    Medicatie gebruik: tijdens gehele studie
    Vragenlijst bij studie start en 14 weken na start
    TWL: 12-, 18-, 24-, en 36 maanden na operatie
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    pragmatic trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    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
    The trail ends when after the last visit of the last subject.
    DE studie eindigd na het laatste bezoek van de laatste deelnemer.
    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 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: 100
    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 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 state100
    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)
    All included patients will be followed up in the regular treatment program after the trial has ended.
    Alle patiënten zullen na het eind van de studie deelnemen aan het reguliere behandelprogramma
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-04
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