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    Clinical Trial Results:
    Multicenter double-blind randomized clinical trial assessing efficacy and safety of exenatide in the treatment of hypothalamic obesity after craniopharyngioma therapy.

    Summary
    EudraCT number
    		 2013-004755-21
    Trial protocol
    		 FR  
    Global end of trial date
    25 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Sep 2026
    First version publication date
    20 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUBX2012/17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02860923
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 rue dubernat, talence, France,
    Public contact
    Clinical trials manager, CHU de Bordeaux, 33 557820329, celine.bairras-martin@chu-bordeaux.fr
    Scientific contact
    Clinical trials manager, CHU de Bordeaux, 33 557820329, celine.bairras-martin@chu-bordeaux.fr
    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
    15 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the change of body weight at month 6 after a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.
    Protection of trial subjects
    Procédure simplifiée (MR001)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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
    France: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    38
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first inclusion: 30/01/2017 Date of last inclusion: 22/02/2018 12 centres in France participated in the study

    Pre-assignment
    Screening details
    		 -Age between 18 and 70 years -History of craniopharyngioma treated by surgery associated or not with radiotherapy, with no sign of recurrence in the last 12 months as attested by an MRI of the hypothalamo-hypophyseal region less than 12 months old -BMI > 30kg/m² with verified weight gain since treatment of the craniopharyngioma

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide group
    Arm description
    		 Treatment with exenatide at the initial dose of 5 μg x 2/day (subcutaneously administered) increased after 4 weeks to 10 μg x 2/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment with exenatide at the initial dose of 5 μg x 2/day (subcutaneously administered) increased after 4 weeks to 10 μg x 2/day

    Arm title
    		 Placebo group
    Arm description
    		 Patients will be maintained on placebo (injected subcutaneously, twice a day)
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will be maintained on placebo (injected subcutaneously, twice a day)

    Number of subjects in period 1
    		Exenatide group Placebo group
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Exenatide group
    Reporting group description
    		 Treatment with exenatide at the initial dose of 5 μg x 2/day (subcutaneously administered) increased after 4 weeks to 10 μg x 2/day

    Reporting group title
    Placebo group
    Reporting group description
    		 Patients will be maintained on placebo (injected subcutaneously, twice a day)

    Reporting group values
    		 Exenatide group Placebo group Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.4 ( 14.8 ) 40.4 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 17
        Male
    		 12 11 23
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 108.8 ( 18.7 ) 106.5 ( 18.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Exenatide group
    Reporting group description
    		 Treatment with exenatide at the initial dose of 5 μg x 2/day (subcutaneously administered) increased after 4 weeks to 10 μg x 2/day

    Reporting group title
    Placebo group
    Reporting group description
    		 Patients will be maintained on placebo (injected subcutaneously, twice a day)

    Primary: Weight difference 6 months after the start of treatment compared to the value at inclusion (M0)

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    End point title
    		 Weight difference 6 months after the start of treatment compared to the value at inclusion (M0)
    End point description
    The weight is measured in the morning on an empty stomach, in a patient in underwear with a scale having a range of 200kg and a 100g scale
    End point type
    Primary
    End point timeframe
    Between inclusion and 6 months after the start of treatment
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    20
    20
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    -2.3 ( 5.9 )
    0.8 ( 5.9 )
    Statistical analysis title
    		 Description of weights between M0 and M6
    Statistical analysis description
    For the main analysis, missing data on the primary endpoint are treated with the "missing=failure" strategy
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1127
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - evolution of abdominal perimeter

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    End point title
    		 Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - evolution of abdominal perimeter
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    14
    15
    Units: centimeter
        arithmetic mean (standard deviation)
    -11.0 ( 19.3 )
    3.3 ( 18.4 )
    Statistical analysis title
    		 Linear modelling of the evolution of waist
    Statistical analysis description
    Model adjusted on waist circumference at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -8.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.12
         upper limit
    		 4.88

    Secondary: Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - evolution of the Body Mass Index (BMI)

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    End point title
    		 Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - evolution of the Body Mass Index (BMI)
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    18
    15
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    -1.2 ( 1.4 )
    -0.5 ( 1.4 )
    Statistical analysis title
    		 Linear modelling of BMI change
    Statistical analysis description
    Model adjusted on BMI at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 0.25

    Secondary: Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of triglycerides

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    End point title
    		 Evolution of the cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    16
    16
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.16 ( 0.66 )
    0.08 ( 0.75 )
    Statistical analysis title
    		 Linear modelling of the evolution of triglycerides
    Statistical analysis description
    Model adjusted on triglycerides at M0
    Comparison groups
    Placebo group v Exenatide group
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 0.24

    Secondary: Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of HDL cholesterol

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    End point title
    		 Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    17
    16
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    0.04 ( 0.25 )
    0.05 ( 0.30 )
    Statistical analysis title
    		 Linear modelling of the evolution of HDL cholester
    Statistical analysis description
    Model adjusted on HDL at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.15

    Secondary: Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of LDL cholesterol

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    End point title
    		 Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    17
    16
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.34 ( 1.10 )
    0.17 ( 0.70 )
    Statistical analysis title
    		 Linear modelling of the evolution of LDL cholester
    Statistical analysis description
    Model adjusted on LDL at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 0.11

    Secondary: Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of fat mass

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    End point title
    		 Evolution of cardio-metabolic risk factors between the beginning and the end of the study taken individually - Evolution of fat mass
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    15
    14
    Units: percent
        arithmetic mean (standard deviation)
    -0.7 ( 1.4 )
    -2.8 ( 5.9 )
    Statistical analysis title
    		 Linear modelling of the evolution of fat mass
    Statistical analysis description
    Model adjusted on fat mass at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 5.03

    Secondary: Evolution of glycaemic control - Evolution of fasting blood glucose between M0 and M6

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    End point title
    		 Evolution of glycaemic control - Evolution of fasting blood glucose between M0 and M6
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    17
    13
    Units: millimole(s)/litre
        arithmetic mean (standard deviation)
    -0.2 ( 0.8 )
    -0.1 ( 0.4 )
    Statistical analysis title
    		 Linear modelling of the evolution of fasting blood
    Statistical analysis description
    Model adjusted on fasting blood glucose at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.35

    Secondary: Evolution of glycaemic control - Evolution of fasting insulin levels between M0 and M6

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    End point title
    		 Evolution of glycaemic control - Evolution of fasting insulin levels between M0 and M6
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    14
    10
    Units: thousand of an international unit/litre
        arithmetic mean (standard deviation)
    0.3 ( 7.0 )
    1.1 ( 5.0 )
    Statistical analysis title
    		 Linear modelling of the evolution of fasting insul
    Statistical analysis description
    Model adjusted on fasting insulin level at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.75
         upper limit
    		 4.92

    Secondary: Evolution of glycemic control - Evolution of the percentage of HbA1C percentage between M0 and M6

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    End point title
    		 Evolution of glycemic control - Evolution of the percentage of HbA1C percentage between M0 and M6
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    14
    10
    Units: percent
        arithmetic mean (standard deviation)
    -0.1 ( 0.3 )
    0.2 ( 0.3 )
    Statistical analysis title
    		 Linear modelling of the evolution of the HbA1C
    Statistical analysis description
    Model adjusted on HbA1C percentage at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.02

    Secondary: Evolution of energy expenditure between the beginning and the end of the study

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    End point title
    		 Evolution of energy expenditure between the beginning and the end of the study
    End point description
    The evolution of energy expenditure is calculated by the evolution of the average number of steps per day since the last visit visit, between M0 and M6
    End point type
    Secondary
    End point timeframe
    At 6 months
    End point values
    		 Exenatide group Placebo group
    Number of subjects analysed
    16
    12
    Units: steps/day
        median (standard deviation)
    -615.8 ( 3028.5 )
    -198.2 ( 3319.1 )
    Statistical analysis title
    		 Evolution of the average number of steps per day
    Statistical analysis description
    Model fitted to the average number of steps per day since the last visit at M0
    Comparison groups
    Exenatide group v Placebo group
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Slope
    Point estimate
    -417.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2893.95
         upper limit
    		 2058.78

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    These averse events are described by Preferred terms (PT)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Reporting group title
    Exenatide group
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo group Exenatide group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 20 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression (10061309)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose (10000381)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture (10037802)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cataract operation (10063797)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine polyp (10046811)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting (10047700)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury (10069339)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas (10015145)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral (10017918)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperlipasaemia (10067725)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatraemia (10020679)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo group Exenatide group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 20 (65.00%)
    19 / 20 (95.00%)
    Vascular disorders
    Haematoma (10018852)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    4
    Hypertension (10020772)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Phlebitis (10034879)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Artificial crown procedure (10058456)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dental prosthesis placement (10052944)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Endodontic procedure (10051085)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia (10003549)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    8 / 20 (40.00%)
         occurrences all number
    2
    8
    Injection site inflammation (10022078)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Injection site pruritus (10022093)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Malaise (10025482)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    4
    Pyrexia (10037660)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy (10048908)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Obstructive airways disorder (10061877)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anorexia nervosa (10002649)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Depression (10012378)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall (10016173)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Incision site inflammation (10064903)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture (10062544)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations (10033557)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness (10013573)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Headache (10019211)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    7 / 20 (35.00%)
         occurrences all number
    1
    8
    Blood and lymphatic system disorders
    Polycythaemia (10036051)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Vertigo (10047340)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye disorders
    Vision blurred (10047513)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Visual impairment (10047571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain (10000081)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 20 (20.00%)
    6 / 20 (30.00%)
         occurrences all number
    4
    6
    Abdominal pain lower (10000084)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Constipation (10010774)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Diarrhoea (10012735)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Eructation (10015137)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Flatulence (10016766)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Gastrooesophageal reflux disease (10017885)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Nausea (10028813)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    10 / 20 (50.00%)
         occurrences all number
    1
    11
    Toothache (10044055)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vomiting (10047700)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    4
    Hepatobiliary disorders
    Cholelithiasis (10008629)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hepatocellular injury (10019837)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hepatic steatosis (10019708)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Polymorphic light eruption (10036087)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pruritus (10037087)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Trichorrhexis (10044625)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Urticaria (10046735)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Endocrine disorders
    Diabetes insipidus (10012599)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia (10003239)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Back pain (10003988)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Bone pain (10006002)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Coccydynia (10009829)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Muscle fatigue (10049565)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms (10028334)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Neck pain (10028836)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Breast abscess (10006171)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Bronchitis (10006451)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Cystitis (10011781)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis (10017888)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hand-foot-and-mouth disease (10019113)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Influenza (10022000)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Laryngitis (10023874)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis (10028810)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 20 (20.00%)
         occurrences all number
    3
    5
    Rhinitis (10039083)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Sialoadenitis (10040628)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Sinusitis (10040753)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Tonsillitis (10044008)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    4
    Tooth abscess (10044016)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tracheitis (10044302)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Urinary tract infection (10046571)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite (10061428)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dyslipidaemia (10058108)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Glucose tolerance impaired (10018429)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Glucose tolerance impaired in pregnancy (10018430)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Hyperlipasaemia (10067725)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Hypernatraemia (10020679)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypoglycaemia (10020993)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Type 2 diabetes mellitus (10067585)
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jul 2016
    1. Update of the inclusions criterias. 2. Update of the non-inclusions criterias. 3. Changes in the strategic part of the study. 4. Adjustment of secondary judgment criteria. 5. Corrections of the research timeline. 6. Adjustment of the participant tracking summary table. 8. Added the coordinates of the coordinating CRA to the list of key contacts. 9. Update of the investigations centers.
    05 Oct 2016
    1. Update of the investigations centers
    01 Dec 2016
    1. Protocol update and harmonization: update of the vigilance unit and pharmacy liaisons, addition of the Clinical Trials number, harmonization of the treatment name in the protocol. 2. Product flow update. 3. Clarification of the blinding procedure. 4. Change to the quality of life questionnaire and modification of the Three Factor Eating Questionnaire version. 5. Update of the participant follow-up summary table. 6. Update of the consent collection procedure. 7. Update of the visit schedule. 8. Correction of the scientific advisory board composition 9. Update of the information and informed consent form. 10. Addition of the Patient Booklet
    05 Apr 2017
    1. Update of secondary objectives 2. Update of inclusion criteria 3. Update of non inclusion criteria 4. Update of the study strategy 5. Update of the benefit/risk ratio and secondary endpoints 6. Modification of the participant follow-up summary table 7. Update of the research process 8. modifications of the procedure for returning used products 9. Update of the appendices 10. Update of the information sheet and informed consent
    06 Sep 2017
    1. Added centre 12. 2. Change of the number of the sent treatment boxes to the centers.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38450721
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