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    Summary
    EudraCT Number:2013-003862-15
    Sponsor's Protocol Code Number:2013-601
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-06
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-003862-15
    A.3Full title of the trial
    Liraglutide in Polycystic Ovary Syndrome

    A randomised, double-blind, placebo-controlled study of the effect of Liraglutide in Polycystic ovary syndrome on risk markers of vascular Thrombosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of early cardiovascular disease in Polycystic Ovary syndrome
    A.3.2Name or abbreviated title of the trial where available
    The LIPT-study
    A.4.1Sponsor's protocol code number2013-601
    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 SponsorJens Faber
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJens Faber
    B.5.2Functional name of contact pointDept. of Medicine O
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 76
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post codeDK-2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538689016
    B.5.5Fax number004538684142
    B.5.6E-mailjens.faber@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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 nameVictoza
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 in pre-filled pen
    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
    Polycystic Ovary Syndrome (PCOS), especialy signs of early cardiovascular disease in women with PCOS.
    E.1.1.1Medical condition in easily understood language
    Polycystic Ovary Syndrome (PCOS), especialy signs of early cardiovascular disease in women with PCOS.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065161
    E.1.2Term Polycystic ovarian syndrome
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo on changes in thrombin generation (TGT), measured as plasma levels of endogenous thrombin potential (ETP).
    E.2.2Secondary objectives of the trial
    To investigate the effect of liraglutide 1.8 mg once daily compared to placebo on changes in
    - Plasma levels of markers of cardiovascular disease: adrenomedullin, atrial natiuretic peptid (ANP), brain natriuretic peptide (BNP), N-terminal part of brain natriuretic peptide (NT-proBNP), Copeptin, high sensitivity c-reative protein (hsCRP).
    - Fat content and distribution: android/gynoid fat, visceral/subcutaneous fat and liver/pancreas fat.
    - Insulin resistance
    - Degree of PCOS: menstruation cycles, degree of hyperandrogenism, morphology of the ovaries (total volume, stromal volume and follicle count), plasma levels of anti-Mullerian hormone (AMH), testosterone
    - Plasma levels of markers of thrombosis: Thrombin generation (peak TGT), plasminogen activator inhibitor 1(PAI-1) and von Willbrandt factor (vWF).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Able to understand the written patient information and to give informed consent
    - PCOS according to the Rotterdam criteria: 2 out of 3 of the following:
    1. Oligo- and/or anovulation
    2. Clinical and/or biochemical signs of hyperandrogenism
    3. Polycystic ovary (ultrasound)
    - Age ≥18 at screening
    - Premenopausal at screening
    - Negative pregnancy test
    - BMI ≥25 at screening
    - BMI<25 at screening and plasma C-peptide > 600 pmol/l
    - On diet treatment for PCOS alone 1 month prior to randomisation
    E.4Principal exclusion criteria
    - Actual or intended Pregnancy during the study period and 1 week after
    - Hormonal contraceptives within 6 weeks prior to randomisation
    - Females of childbearing potential who are not using adequate contraceptive methods according to Danish Medicines Agency’s definition. Since the use of hormonal contraception is an exclusion criterion in the study, the women should use adequate non-hormonal contraceptive methods such as cobber IUD (intra uterine device) or double barrier (simultaneous use of condom and pessary). We offer a free cobber IUD for the women included in the study.
    - Nursing women
    - Smoking > 10 cigarettes per day at screening
    - Type 1 or 2 diabetes mellitus at screening
    - Hypertension (BP >140/90) untreated, or treated hypertension at screening
    - The use of medications known to influence the haemostatic-thrombotic system (as glucocorticoids inclusive inhaled preparations, BP treatment drugs)
    - Use of GLP-1 receptor agonists (Exenatide, liraglutide or other) or any DPP-IV inhibitor within 3 months prior to randomisation
    - Known or suspected hypersensitivity to trial product or related products
    - Alcohol/drug abuse
    - Cancer
    - Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) at screening
    - Inflammatory bowel disease
    - Acute or chronic pancreatitis
    - MEN2
    - Compromised kidney function (GFR < 60 ml/min), dialysis or kidney transplantation at screening
    - Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
    - Simultaneous participation in any other clinical intervention trial
    E.5 End points
    E.5.1Primary end point(s)
    Changes from randomisation to end of treatment after 26 weeks of intervention in TGT (measured as ETP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 26(+/-2) weeks of intervention.
    E.5.2Secondary end point(s)
    Changes from randomisation to end of treatment after 26 weeks of intervention in:
    - p-Adrenomedullin
    - p-ANP
    - p-BNP, NT-proBNP
    - p-Copeptin
    - p-hsCRP
    - Body composition including android and gynoid fat measured by DEXA
    - Visceral and subcutaneous fat measured by MR
    - Fat content in lever and pancreas measured by 1H MR-spectroscopy
    - Insulin resistance measured as HOMA-1 (plasma Insulin (mU/L) x blood glucose (mmol/L)/22,5) and HOMA-2 using plasma C-peptide instead of plasma insulin, as well as measured by the Matsuda model, which measures whole-body insulin sensitivity.
    - TGT (Peak)
    - p-PAI-1
    - p-vWF
    - p-AMH
    - Menstruation cycles based on bleeding diaries
    - Degree of hyperandrogenism determined by the Ferriman-Gallway hirsutism scale.
    - Plasma levels of free and total testosterone
    - Total ovarian volume, stromal volume and follicle count based on 3D ultrasound and stereological calculations
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 26(+/-2) weeks of intervention.
    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 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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 70
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Information not present in EudraCT
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    We offer a post-study consultation where we will inform the woman about the results of her examinations and offer her treatment of PCOS accoring to National Guidelines.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-21
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