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    Clinical Trial Results:
    The effect of liraglutide on pancreatic hormones and its size

    Summary
    EudraCT number
    		 2016-004768-20
    Trial protocol
    		 DK  
    Global end of trial date
    04 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2020
    First version publication date
    21 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LIRAP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03520062
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Copenhagen
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark,
    Public contact
    Nicolai Jacob Wewer Albrechtsen and Jens Juul Holst, University of Copenhagen, +45 29649329, hgk795@ku.dk
    Scientific contact
    Nicolai Jacob Wewer Albrechtsen and Jens Juul Holst, University of Copenhagen, +45 29649329, hgk795@ku.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
    01 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate if liraglutide increases the volumen of the pancreas and as a consequence increases plasma levels of amylase and lipase
    Protection of trial subjects
    No certain protection was included
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Obese men were recruited by advertisement at forsoegspersoner.dk and from department of endocrinology, hvidovre hospital. The recruitment was initiated in march 2017 and ended in march 2019

    Pre-assignment
    Screening details
    		 Participants were overweight but otherwise healthy men, who were recruited through advertisement. Inclusion criteria were men; age 18-65 years; body mass index (BMI) 26-50 kg/m2; and written informed consent. Key exclusion criteria were type 1 or 2 diabetes (HbA1c > 42 mmol/mol (6·0%)); severe diseases of the heart, lung, liver, kidney (estimated g

    Period 1
    Period 1 title
    overall trial baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Liraglutide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxenda
    Investigational medicinal product code
    Other name
    Liraglutide
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Following the baseline examinations, treatment with liraglutide (Saxenda, Novo Nordisk, Søborg, Denmark) injections once daily was initiated at a dose of 0·6 mg daily for the first week. Doses of liraglutide were titrated by additional 0·6 mg per week if tolerated until the maximum dose of 3·0 mg was achieved. The titration of liraglutide was supervised by weekly telephone consultations with evaluation of any side effects. In case of intolerable side effects, the study medication dosage could be reduced until recovery from symptoms occurred; however, all subjects in the study did reach the maximum dose of 3·0 mg. Adherence to study medication was evaluated by collection of all injection pens and, in addition, blood was sampled for analysis of plasma concentrations of liraglutide. Visits were repeated 4 weeks and 6 weeks after initiation of treatment, and a follow-up visit was performed 3 weeks after discontinuation of liraglutide treatment (follow-up).

    Number of subjects in period 1
    		Liraglutide
    Started
    17
    Completed
    16
    Not completed
    1
         unable to fit the MR scanner
    1
    Period 2
    Period 2 title
    overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Liraglutide
    Arm description
    		 This was an open-label clinical study with prospective evaluation of pancreatic enzymes and MRI determination of pancreatic volume before (‘Baseline’), during initiation and titration of liraglutide (‘Week 4’) towards maximum dose of 3·0 mg, after 2 weeks of steady state treatment with liraglutide (‘Week 6’), and at a follow-up visit 3 weeks after discontinuation of liraglutide treatment (‘Follow-up’),
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxenda
    Investigational medicinal product code
    Other name
    Liraglutide
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Following the baseline examinations, treatment with liraglutide (Saxenda, Novo Nordisk, Søborg, Denmark) injections once daily was initiated at a dose of 0·6 mg daily for the first week. Doses of liraglutide were titrated by additional 0·6 mg per week if tolerated until the maximum dose of 3·0 mg was achieved. The titration of liraglutide was supervised by weekly telephone consultations with evaluation of any side effects. In case of intolerable side effects, the study medication dosage could be reduced until recovery from symptoms occurred; however, all subjects in the study did reach the maximum dose of 3·0 mg. Adherence to study medication was evaluated by collection of all injection pens and, in addition, blood was sampled for analysis of plasma concentrations of liraglutide. Visits were repeated 4 weeks and 6 weeks after initiation of treatment, and a follow-up visit was performed 3 weeks after discontinuation of liraglutide treatment (follow-up).

    Number of subjects in period 2
    		Liraglutide
    Started
    16
    Completed
    14
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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

    Reporting group values
    		 overall trial baseline Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 17 17
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 39 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -
    Reporting group title
    Liraglutide
    Reporting group description
    		 This was an open-label clinical study with prospective evaluation of pancreatic enzymes and MRI determination of pancreatic volume before (‘Baseline’), during initiation and titration of liraglutide (‘Week 4’) towards maximum dose of 3·0 mg, after 2 weeks of steady state treatment with liraglutide (‘Week 6’), and at a follow-up visit 3 weeks after discontinuation of liraglutide treatment (‘Follow-up’),

    Subject analysis set title
    primary outcome
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Six week effect of liraglutide on pancreatic volume

    Subject analysis set title
    Comparison between baseline and after intervention
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Delta values between baseline and 6 week after intervention with liraglutide for pancreatic volume, amylase and lipase and 4 weeks for FLT-uptake

    Primary: Pancreatic Volume

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    End point title
    		 Pancreatic Volume
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to 6 week after intervention
    End point values
    		 Liraglutide Comparison between baseline and after intervention
    Number of subjects analysed
    14
    14
    Units: cm3
        number (not applicable)
    0.2
    0.2
    Statistical analysis title
    		 Paired Analyses on Primary Endpoint
    Comparison groups
    Liraglutide v Comparison between baseline and after intervention
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Paired Analyses

    Secondary: FLT uptake in the Pancreas

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    End point title
    		 FLT uptake in the Pancreas
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Four weeks after Intervention
    End point values
    		 Liraglutide Comparison between baseline and after intervention
    Number of subjects analysed
    14
    14
    Units: g/mL
        number (not applicable)
    0.09
    0.09
    Statistical analysis title
    		 Paired Analyses on Secondary Endpoint
    Comparison groups
    Liraglutide v Comparison between baseline and after intervention
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Plasma Amylase

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    End point title
    		 Plasma Amylase
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Six week after intervention
    End point values
    		 Liraglutide Comparison between baseline and after intervention
    Number of subjects analysed
    14
    14
    Units: U/L
        number (not applicable)
    7
    7
    Statistical analysis title
    		 Paired Analyses on Secondary Endpoint
    Comparison groups
    Liraglutide v Comparison between baseline and after intervention
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Plasma Lipase

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    End point title
    		 Plasma Lipase
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Six week after intervention
    End point values
    		 Liraglutide Comparison between baseline and after intervention
    Number of subjects analysed
    14
    14
    Units: U/L
        number (not applicable)
    19
    19
    Statistical analysis title
    		 Paired Analyses on Secondary Endpoint
    Comparison groups
    Liraglutide v Comparison between baseline and after intervention
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline to Followup
    Adverse event reporting additional description
    All participants reported adverse events. Most of these were gastrointestinal, observed in 79% of completers (nausea in 57%, diarrhea in 21%, abdominal pain in 14%, and vomiting in 14% of participants). Nearly half of the adverse events were mild and transient, and all completers followed the planned titration regimen and reached the maximum dose o
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Adverse Event
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse Event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 17 (17.65%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Obstipation
    Additional description: One day of hospitalization due to flatulence and abdominal pain caused by obstipation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    postoperative
    Additional description: elective knee surgery and subsequent admission due to postoperative pain in the knee
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Adverse Event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 17 (76.47%)
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    13 / 17 (76.47%)
         occurrences all number
    13

    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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    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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