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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2013-003862-15
    Trial protocol
    		 DK  
    Global end of trial date
    21 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions
    Summary report(s)
    		 Manuscript on primary end point - LIPT

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-601
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02073929
    WHO universal trial number (UTN)
    		 U1111-1134-6841
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev ringvej 75, Copenhagen, Denmark, DK-2730
    Public contact
    Dept. of Medicine O, Jens Faber, 0045 38689016, jens.faber@regionh.dk
    Scientific contact
    Dept. of Medicine O, Jens Faber, 0045 38689016, jens.faber@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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).
    Protection of trial subjects
    Patients were treated according to the Helsinki Declaration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 72
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    72
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 As described in Nylander et al., Endocr Connect. 2017 Feb;6(2):89-99. doi: 10.1530/EC-16-0113.

    Pre-assignment
    Screening details
    		 As described in CONSORT-flow in Nylander et al., Endocr Connect. 2017 Feb;6(2):89-99. doi: 10.1530/EC-16-0113.

    Period 1
    Period 1 title
    basaeline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 treatment with Liraglutide 1,8 mg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    daily s.c. injection of Liraglutide 1.8 mg

    Arm title
    		 Placebo
    Arm description
    		 Injection with saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    En pen containing saline instead of active drug
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daily s.c. injection with pen containing saline

    Number of subjects in period 1
    		Active Placebo
    Started
    48
    24
    Completed
    48
    24
    Period 2
    Period 2 title
    overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 treatment with liraglutide 1.8 mg/day for 6 month
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    daily s.c. injection of Liraglutide 1.8 mg

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    En pen containing saline instead of active drug
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daily s.c. injection with pen containing saline

    Number of subjects in period 2
    		Active placebo
    Started
    48
    24
    Completed
    48
    24

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 treatment with Liraglutide 1,8 mg/day

    Reporting group title
    Placebo
    Reporting group description
    		 Injection with saline
    Reporting group title
    Active
    Reporting group description
    		 treatment with liraglutide 1.8 mg/day for 6 month

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: Endogenous thrombin potential (ETP)

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    End point title
    		 Endogenous thrombin potential (ETP)
    End point description
    Change in ETP after 6 month of Liraglutide/placebo treatment
    End point type
    Primary
    End point timeframe
    Measured before and at the end of six months of treatment with liraglutide 1.8 mg/day or placebo
    End point values
    		 Active placebo
    Number of subjects analysed
    44
    24
    Units: nmol/L x min
        median (confidence interval 95%)
    -57.6 (-132.3 to 17.2)
    -8.2 (-98.7 to 82.3)
    Statistical analysis title
    		 Analysis of EPT
    Statistical analysis description
    A sample size calculation based on an estimated standard deviation of 130 units obtained from in-house data, declared 63 subjects, randomized 2:1, needed for 80% power to find a difference in effect size of 100nmol/min of ETP. This effect size was supported by a previous study finding a similar reduction in ETP with a 5% reduction in BMI (22). To allow for drop-outs, 72 women were randomized.
    Comparison groups
    Active v placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 5
    Method
    		 t-test, 2-sided
    Parameter type
    		 mixed model with maximum likelihood
    Confidence interval
    Notes
    [1] - In the initial protocol, we planned on calculating the between-group difference using an unpaired t-test on the intention-to-treat population. As a mixed model with maximum likelihood is a more optimal way of analyzing repeated measurements, we have chosen this statistic approach, and between-group differences in treatment effect are assessed using a repeated measurements mixed model (with maximum likelihood) with study drug as between-subjects effect and visit (time) as within

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    March 2014- December 2015.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Active group
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active group placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Active group placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 47 (63.83%)
    11 / 23 (47.83%)
    General disorders and administration site conditions
    Nausea
    Additional description: Nausea Vomiting Diarrhea Constipation Gallstone pain Cholecysectomy Dizziness upper resp tract infektion urinary tract infektion rash
         subjects affected / exposed
    30 / 47 (63.83%)
    11 / 23 (47.83%)
         occurrences all number
    30
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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