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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled trial to assess safety, tolerability and pharmacokinetics of liraglutide in obese adolescent subjects aged 12 to 17 years.

    Summary
    EudraCT number
    		 2012-000038-20
    Trial protocol
    		 DE  
    Global end of trial date
    26 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    21 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN8022-3967
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01789086
    WHO universal trial number (UTN)
    		 U1111-1126-8119
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR,1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000128-PIP02-09
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of liraglutide at doses up to 3.0 mg in an obese adolescent population aged 12-17 years and Tanner stage 2-5.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (59th WMA General Assembly, Seoul, 2008) and ICH Good Clinical Practice (01 May 1996) and 21 CFR 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    07 Feb 2013
    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
    Germany: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at one site in Germany.

    Pre-assignment
    Screening details
    		 Not applicable.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Liraglutide 3.0 mg
    Arm description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of liraglutide was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of liraglutide was 0.6 mg/day, given once-daily subcutaneous abdominal injections in the morning. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day.

    Arm title
    		 Placebo
    Arm description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of placebo was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Initial dose of placebo was 0.6 mg/day, given once-daily subcutaneous abdominal injections in the morning. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day.

    Number of subjects in period 1
    		Liraglutide 3.0 mg Placebo
    Started
    14
    7
    Completed
    13
    7
    Not completed
    1
    0
         Storage temperature deviation of trial product
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of liraglutide was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of placebo was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Reporting group values
    		 Liraglutide 3.0 mg Placebo Total
    Number of subjects
    		 14 7 21
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 14 7 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.1 ( 0.9 ) 14.4 ( 1.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 3 14
        Male
    		 3 4 7
    Body Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 103.5 ( 12.8 ) 109.6 ( 30.8 ) -
    Boby Mass Index (BMI)
    Units: Kg/m2
        arithmetic mean (standard deviation)
    		 36.5 ( 3.7 ) 35.7 ( 5.4 ) -
    Glycosylated Haemoglobin (HbA1C)
    Units: Percentage
        arithmetic mean (standard deviation)
    		 5.4 ( 0.3 ) 5.5 ( 0.3 ) -
    Fasting Plasma Glucose (FPG)
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 5.25 ( 0.45 ) 5.47 ( 0.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of liraglutide was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of placebo was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Primary: Number of treatment emergent adverse events (TEAEs) recorded.

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    End point title
    		 Number of treatment emergent adverse events (TEAEs) recorded. [1]
    End point description
    An adverse event is defined as treatment emergent if it has onset date on or after the first day of exposure and not later than the follow-up visit or has onset date before the first day of exposure and increases in severity during treatment and no later than the follow-up visit.
    End point type
    Primary
    End point timeframe
    From time of first dosing and until the end of the post-treatment follow-up period (i.e., 5-14 days after the last dosing visit).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint investigates safety and is analysed using descriptive statistics, and thus no statistical analysis is performed.
    End point values
    		 Liraglutide 3.0 mg Placebo
    Number of subjects analysed
    14 [2]
    7 [3]
    Units: Number of events
    86
    7
    Notes
    [2] - 86 adverse events were reported by 14 subjects.
    [3] - 7 adverse events were reported by 4 subjects.
    No statistical analyses for this end point

    Secondary: Incidence of anti-liraglutide antibody.

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    End point title
    		 Incidence of anti-liraglutide antibody.
    End point description
    Blood samples for determination of anti-liraglutide antibodies were drawn at the screening visit (visit 1) and the follow-up visit (visit 8). Samples were analysed for anti-liraglutide antibody findings .
    End point type
    Secondary
    End point timeframe
    Time frame: Week 0 to week 6 + 5 to 14 days of subsequent follow-up.
    End point values
    		 Liraglutide 3.0 mg Placebo
    Number of subjects analysed
    14
    7
    Units: Incidence of anti-liraglutide antibody
    0
    0
    No statistical analyses for this end point

    Secondary: Ctrough-at steady state at each dose step.

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    End point title
    		 Ctrough-at steady state at each dose step. [4]
    End point description
    In order to obtain Ctrough (liraglutide plasma concentrations) values at steady state at each dose-escalation step, one blood sample was drawn prior to the subjects taking their daily dose of liraglutide at visits 3 (7 days), 4 (14 days), 5 (21 days), 6 (28 days) and 7 (35 days).
    End point type
    Secondary
    End point timeframe
    At 7, 14, 21, 28 and 35 days of treatment.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Samples from liraglutide treated subjects were included for pharmacokinetic analysis. Samples from placebo treated subjects were not considered for pharmacokinetic analysis, so placebo arm is not included in this endpoint.
    End point values
    		 Liraglutide 3.0 mg
    Number of subjects analysed
    13 [5]
    Units: pmol/L
    geometric mean (geometric coefficient of variation)
        Day 7
    5596 ( 31.31 )
        Day 14
    10263 ( 26.5 )
        Day 21
    13800 ( 38.25 )
        Day 28
    12788 ( 77.31 )
        Day 35
    25188 ( 40.05 )
    Notes
    [5] - Only 12 subjects contributed in Ctrough-at steady state at day 35.
    No statistical analyses for this end point

    Secondary: Model-derived AUCτ at steady-state.

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    End point title
    		 Model-derived AUCτ at steady-state. [6]
    End point description
    Area under the concentration-time (AUCτ) curve at steady state from 0−24 hours, after dose.
    End point type
    Secondary
    End point timeframe
    Last dose day, after up to 6 weeks treatment.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Samples from liraglutide treated subjects were included for pharmacokinetic analysis. Samples from placebo treated subjects were not considered for pharmacokinetic analysis, so placebo arm is not included in this endpoint.
    End point values
    		 Liraglutide 3.0 mg
    Number of subjects analysed
    13
    Units: nM*h
        geometric mean (confidence interval 95%)
    836 (745 to 962)
    No statistical analyses for this end point

    Secondary: Model-derived t½ at steady-state.

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    End point title
    		 Model-derived t½ at steady-state. [7]
    End point description
    Mean plasma half-life (t½) of liraglutide, at steady-state.
    End point type
    Secondary
    End point timeframe
    Last dose day, after up to 6 weeks treatment.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Samples from liraglutide treated subjects were included for pharmacokinetic analysis. Samples from placebo treated subjects were not considered for pharmacokinetic analysis, so placebo arm is not included in this endpoint.
    End point values
    		 Liraglutide 3.0 mg
    Number of subjects analysed
    13
    Units: hour
        geometric mean (confidence interval 95%)
    8.6 (8.5 to 8.7)
    No statistical analyses for this end point

    Secondary: Model-derived CL/F at steady-state.

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    End point title
    		 Model-derived CL/F at steady-state. [8]
    End point description
    Mean apparent clearance (CL/F) of liraglutide at steady state.
    End point type
    Secondary
    End point timeframe
    Last dose day, after up to 6 weeks treatment
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Samples from liraglutide treated subjects were included for pharmacokinetic analysis. Samples from placebo treated subjects were not considered for pharmacokinetic analysis, so placebo arm is not included in this endpoint.
    End point values
    		 Liraglutide 3.0 mg
    Number of subjects analysed
    13
    Units: Litre/hour
        geometric mean (confidence interval 95%)
    0.96 (0.85 to 1.11)
    No statistical analyses for this end point

    Secondary: Model-derived V/F at steady-state.

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    End point title
    		 Model-derived V/F at steady-state. [9]
    End point description
    Mean apparent volume of distribution (V/F) of liraglutide, at steady state.
    End point type
    Secondary
    End point timeframe
    Last dose day, after up to 6 weeks treatment.
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Samples from liraglutide treated subjects were included for pharmacokinetic analysis. Samples from placebo treated subjects were not considered for pharmacokinetic analysis, so placebo arm is not included in this endpoint.
    End point values
    		 Liraglutide 3.0 mg
    Number of subjects analysed
    13
    Units: Litre
        geometric mean (confidence interval 95%)
    10.3 (9.5 to 11.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening visit and until the end of the post-treatment follow-up period (i.e., 5-14 days after the last dosing visit).
    Adverse event reporting additional description
    An adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of liraglutide was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Eligible subjects were randomised to receive liraglutide or placebo in 2:1 ratio, subcutaneously (s.c., under skin), for a period of 5−6 weeks. Initial dose of placebo was 0.6 mg/day. The dose was escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day. Follow-up visit was planned 5-14 days after the end of treatment.

    Serious adverse events
    		 Liraglutide 3.0 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 7 (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 3.0 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    4 / 7 (57.14%)
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 14 (50.00%)
    0 / 7 (0.00%)
         occurrences all number
    9
    0
    Dizziness
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Migraine
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Visual field defect
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 14 (50.00%)
    2 / 7 (28.57%)
         occurrences all number
    17
    3
    Nausea
         subjects affected / exposed
    7 / 14 (50.00%)
    0 / 7 (0.00%)
         occurrences all number
    13
    0
    Vomiting
         subjects affected / exposed
    5 / 14 (35.71%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Diarrhoea
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    5
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0

    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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