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    Clinical Trial Results:
    Treatment of bile acid malabsorption with liraglutid

    Summary
    EudraCT number
    		 2018-003575-34
    Trial protocol
    		 DK  
    Global end of trial date
    01 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2022
    First version publication date
    09 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    301084
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev og Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 7, Hellerup, Denmark, 2900
    Public contact
    Stene Diabetes Center Copenhagen,, Gentofte Hospital, University of Copenhagen, martin.lund.kaarhus@regionh.dk
    Scientific contact
    Stene Diabetes Center Copenhagen,, Gentofte Hospital, University of Copenhagen, 0045 38674266, martin.lund.kaarhus@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
    06 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to examine the influence of liraglutide on individuals suffering from bile acid malabsorption (BAM), in a randomised double-blinded, double dummy parallel Group non-inferiority study.
    Protection of trial subjects
    Visits at the experimental site
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2019
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    45
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 diagnosed Subjects were asked if a MD was allowed to contact them for further information about the study

    Pre-assignment
    Screening details
    		 Lægelig vurdering samt opfyldelse af inklusionskriterier

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 baseline
    Arm description
    		 -
    Arm type
    		 baseline

    Investigational medicinal product name
    none
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    0

    Number of subjects in period 1
    		baseline
    Started
    52
    Completed
    52
    Period 2
    Period 2 title
    intervention
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for dispersion for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.6 to 1.8 mg

    Arm title
    		 Colesevelam
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    colesevelam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1.875 g twice daily

    Number of subjects in period 2
    		Liraglutide Colesevelam
    Started
    26
    26
    Completed
    25
    25
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 52 52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 45 45
        From 65-84 years
    		 7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.7 ± 13.3 -
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Colesevelam
    Reporting group description
    		 -

    Primary: Risk difference between interventions

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    End point title
    		 Risk difference between interventions
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks of intervention
    End point values
    		 Liraglutide Colesevelam
    Number of subjects analysed
    26
    26
    Units: %
    56
    23
    Statistical analysis title
    		 Risk difference
    Comparison groups
    Liraglutide v Colesevelam
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -1
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From intervention start and three weeks after last intervention
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no specific
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Colesevelam
    Reporting group description
    		 -

    Serious adverse events
    		 Liraglutide Colesevelam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)
    0 / 26 (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: 5%
    Non-serious adverse events
    		 Liraglutide Colesevelam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 26 (23.08%)
    1 / 26 (3.85%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 26 (23.08%)
    1 / 26 (3.85%)
         occurrences all number
    26
    26

    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? Yes
    Date
    Interruption
    Restart date
    16 Mar 2020
    SARSCOV2 virus paused the project for 4 months
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35868334
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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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