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    Clinical Trial Results:
    Does Glucagon-like Peptide 1 (GLP-1) receptor stimulation reduce alcohol intake in patients with alcohol dependence?

    Summary
    EudraCT number
    		 2016-003343-11
    Trial protocol
    		 DK  
    Global end of trial date
    06 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2022
    First version publication date
    13 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLP1ALCOHOL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03232112
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Psychiatric Centre Copenhagen
    Sponsor organisation address
    Edel Sauntes Allé 10, 2100 København Ø, Copenhagen, Denmark, 2100
    Public contact
    Professor Anders Fink-Jensen, Professor Anders Fink-Jensen, +45 22755843, Anders.Fink-Jensen@regionh.dk
    Scientific contact
    Professor Anders Fink-Jensen, Professor Anders Fink-Jensen, +45 22755843, Anders.Fink-Jensen@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
    10 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to investigate the effects of the GLP-1 receptor agonist Bydureon® on total number of heavy drinking days from baseline to follow up after 26 weeks of treatment in patients with alcohol dependence in a 26-weeks double-blinded, randomized placebo-controlled clinical trial. )). Furthermore, patients will be approached 26 weeks after end participation, in order to evaluate whether or not there is a long-term effect of the intervention on the TLFB questionnaire.
    Protection of trial subjects
    The patients could call a phoneline 24/7, if needed due to side-effects or ilness
    Background therapy
    		 All patients included recieved standardized cognitive behavioral therapy while included
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Aug 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    135
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from 7th of August 2017 to 1st of October 2019. All patients were recruited from four outpatient alcohol treatment facilities in the suburbs of Copenhagen or through a project webpage. The 25 healthy controls were recruited via the project webpage.

    Pre-assignment
    Screening details
    		 In total 156 patients were screened for eligibility. 29 were excluded due to other substance disorder, paraclinic above upper limit, withdrawal symptoms, AUDIt score below 15, a medical record of alcohol-related withdrawal seizures/pancreatitis, less than 5 hevy drinking days or absent from first injection.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    All patients were blindfolded when recieving the assigned treatment by an unblinded nurse. The unblinded nurses, were not involved in any other trial related activity.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Bydureon once weekly, 2 mg sc
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bydureon 2 mg powder and solvent for prolonged-release suspension for injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 mg sc

    Arm title
    		 placebo
    Arm description
    		 saline 2 ml sc
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Cutaneous use
    Dosage and administration details
    2 ml were given sc

    Number of subjects in period 1 [1]
    		Intervention placebo
    Started
    62
    65
    Completed
    26
    32
    Not completed
    36
    33
         Consent withdrawn by subject
    5
    11
         Adverse event, non-fatal
    14
    2
         Lost to follow-up
    7
    8
         Lack of efficacy
    10
    12
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the people included, 25 individuals were healthy controls for the fMRI brain imaging. They are not included in the baseline data.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Bydureon once weekly, 2 mg sc

    Reporting group title
    placebo
    Reporting group description
    		 saline 2 ml sc

    Reporting group values
    		 Intervention placebo Total
    Number of subjects
    		 62 65 127
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.1 ± 10.8 52.5 ± 10.0 -
    Gender categorical
    Units: Subjects
        Female
    		 25 26 51
        Male
    		 37 39 76

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Bydureon once weekly, 2 mg sc

    Reporting group title
    placebo
    Reporting group description
    		 saline 2 ml sc

    Primary: Change in heavy drinking days

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    End point title
    		 Change in heavy drinking days
    End point description
    A heavy drinking day is defined as days with an excess intake of 60/48 grams of alcohol per day (men and women, respectively). Self-reported with the TLFB-method.
    End point type
    Primary
    End point timeframe
    week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: percentage points
        arithmetic mean (confidence interval 95%)
    -19.6 (-27.4 to -11.8)
    -26.8 (-34.4 to -19.2)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.37
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Total alcohol consumption

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    End point title
    		 Total alcohol consumption
    End point description
    Self-reported with the TLFB-method
    End point type
    Secondary
    End point timeframe
    week 0- week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: g/30 days
        arithmetic mean (confidence interval 95%)
    -1304 (-1584 to -1024)
    -1313 (-1586 to -1039)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.86
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Days without alcohol consumption

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    End point title
    		 Days without alcohol consumption
    End point description
    Self-reported with the TLFB-method
    End point type
    Secondary
    End point timeframe
    week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: percentage points
        arithmetic mean (confidence interval 95%)
    11.3 (3.6 to 18.9)
    20.6 (13.1 to 28.1)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.11
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in PACS score

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    End point title
    		 Change in PACS score
    End point description
    Penn Alcohol Craving Scale (PACS)
    End point type
    Secondary
    End point timeframe
    week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: points
        arithmetic mean (confidence interval 95%)
    -5.4 (-7.0 to -3.9)
    -7.3 (-8.8 to -5.8)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.42
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in AUDIT score

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    End point title
    		 Change in AUDIT score
    End point description
    Alcohol Use Disorders Identification Test (AUDIT)
    End point type
    Secondary
    End point timeframe
    Week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: points
        arithmetic mean (confidence interval 95%)
    -7.0 (-8.8 to -5.1)
    -8.2 (-10.0 to -6.5)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.59
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in DUDIT score

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    End point title
    		 Change in DUDIT score
    End point description
    Drug Use Disorders Identification Test (DUDIT) score
    End point type
    Secondary
    End point timeframe
    week o - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: points
        arithmetic mean (confidence interval 95%)
    -7.3 (-7.7 to -6.9)
    -8.3 (-8.9 to -7.8)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 > 0.001
    Method
    		 ANOVA
    Confidence interval
    Notes
    [6] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in GGT

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    End point title
    		 Change in GGT
    End point description
    Liverparameter gamma-glutamyltransferase (GGT)
    End point type
    Secondary
    End point timeframe
    week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: U/L
        arithmetic mean (confidence interval 95%)
    -13.6 (-42.8 to 15.6)
    -16.5 (-45.0 to 12.0)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.84
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in ALAT

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    End point title
    		 Change in ALAT
    End point description
    Liverparameter alanine aminotransferase (ALAT)
    End point type
    Secondary
    End point timeframe
    week 0 - week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: U/L
        arithmetic mean (confidence interval 95%)
    -3.7 (-9.7 to 2.2)
    -7.9 (-13.7 to -2.1)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.68
    Method
    		 ANOVA
    Confidence interval
    Notes
    [8] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in phosphatidyl-ethanol (PEth)

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    End point title
    		 Change in phosphatidyl-ethanol (PEth)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: µmol/l
        arithmetic mean (confidence interval 95%)
    -0.09 (-0.3 to 0.2)
    -0.03 (-0.3 to 0.2)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.64
    Method
    		 ANOVA
    Confidence interval
    Notes
    [9] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Pancreas type Amylase

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    End point title
    		 Pancreas type Amylase
    End point description
    Safety measurement
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: U/L
        arithmetic mean (confidence interval 95%)
    4.1 (2.0 to 6.3)
    -0.4 (-2.5 to 1.6)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.054
    Method
    		 ANOVA
    Confidence interval
    Notes
    [10] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in mean cell volume (MCV)

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    End point title
    		 Change in mean cell volume (MCV)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: fL
        arithmetic mean (confidence interval 95%)
    -1.8 (-2.6 to -1.0)
    -1.3 (-2.1 to -0.5)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.45
    Method
    		 ANOVA
    Confidence interval
    Notes
    [11] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Changes in body weight

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    End point title
    		 Changes in body weight
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: kg
        arithmetic mean (confidence interval 95%)
    -2.9 (-4.3 to 9.4)
    -0.5 (-1.8 to 0.9)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 = 0.07
    Method
    		 ANOVA
    Confidence interval
    Notes
    [12] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in Systolic blood pressure

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    End point title
    		 Change in Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -4.3 (-7.7 to -0.8)
    -4.2 (-7.6 to -0.9)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0.93
    Method
    		 ANOVA
    Confidence interval
    Notes
    [13] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in diastolic blood pressure

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    End point title
    		 Change in diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: mm Hg
        arithmetic mean (confidence interval 95%)
    -1.9 (-4.39 to 0.6)
    0.2 (-2.2 to 2.6)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0.32
    Method
    		 ANOVA
    Confidence interval
    Notes
    [14] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in pulse

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    End point title
    		 Change in pulse
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: p
        arithmetic mean (confidence interval 95%)
    5.0 (2.6 to 7.4)
    2.4 (0.1 to 4.7)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.36 [15]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [15] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in HbA1c

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    End point title
    		 Change in HbA1c
    End point description
    overall glycaemic controlparameters (HbA1c)
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: mmol/mol
        arithmetic mean (confidence interval 95%)
    -0.7 (-1.3 to -0.1)
    1.4 (0.8 to 2.0)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 = 0.011
    Method
    		 ANOVA
    Confidence interval
    Notes
    [16] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Change in SF-36 score

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    End point title
    		 Change in SF-36 score
    End point description
    Measures of health (Short Form Health Survey (SF-36)
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: points
        arithmetic mean (confidence interval 95%)
    7.9 (4.9 to 10.9)
    12.3 (9.3 to 15.2)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.48
    Method
    		 ANOVA
    Confidence interval
    Notes
    [17] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Changes in Symptom Checklist (SCL-92)

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    End point title
    		 Changes in Symptom Checklist (SCL-92)
    End point description
    life quality measurement - Symptom Checklist (SCL-92)
    End point type
    Secondary
    End point timeframe
    Week 0 – week 26
    End point values
    		 Intervention placebo
    Number of subjects analysed
    62
    65
    Units: points
        arithmetic mean (confidence interval 95%)
    -0.2 (-0.3 to -0.1)
    -0.4 (-0.5 to -0.3)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 = 0.38
    Method
    		 ANOVA
    Confidence interval
    Notes
    [18] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Secondary: Heavy drinking days 6 months after end of trial

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    End point title
    		 Heavy drinking days 6 months after end of trial
    End point description
    Longterm effects of the intervention
    End point type
    Secondary
    End point timeframe
    week 26 to 6 months followup
    End point values
    		 Intervention placebo
    Number of subjects analysed
    29
    26
    Units: percentage points
        arithmetic mean (confidence interval 95%)
    -3.2 (-5.9 to -0.5)
    -5.6 (-8.4 to -2.7)
    Statistical analysis title
    		 ANOVA from baseline to last observation endpoint
    Statistical analysis description
    All continuous outcomes were analyzed with an ANOVA adjusted for baseline until the last observational endpoint, and missing data were imputed with the use of multiple imputations in the mice package in R software version 3.6.0, method = “pmm” (predictive mean matching), and the number of imputed datasets = 100. No adjustment for covariates was performed.
    Comparison groups
    Intervention v placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.18
    Method
    		 ANOVA
    Confidence interval
    Notes
    [19] - No superiority, equivalence, or noninferiority hypothesis testing framework were performed

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events were assesed at the week 4, week 12, week 20, and week 26 session. Patients were encouraged to make contact with the investigators at any time, and not wait for the assessments, if they experienced adverse events.
    Adverse event reporting additional description
    Patients were asked if they had experienced any adverse events since the last meeting.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Bydureon

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 62 (17.74%)
    8 / 65 (12.31%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Alcohol withdrawal syndrome
    Additional description: Number of hospitalizations (4 patients in each group, some admitted twice)
         subjects affected / exposed
    9 / 62 (14.52%)
    6 / 65 (9.23%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Death
    Additional description: No known cause of the death
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Appendicitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide
    Additional description: 7 weeks after the end of participation in the trial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Intervention Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 62 (96.77%)
    60 / 65 (92.31%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 65 (3.08%)
         occurrences all number
    3
    2
    Headache
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 65 (6.15%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Weight gain
         subjects affected / exposed
    12 / 62 (19.35%)
    31 / 65 (47.69%)
         occurrences all number
    12
    31
    Weight loss overall
         subjects affected / exposed
    42 / 62 (67.74%)
    26 / 65 (40.00%)
         occurrences all number
    42
    26
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 65 (4.62%)
         occurrences all number
    1
    3
    Reflux gastritis
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 65 (3.08%)
         occurrences all number
    3
    2
    Gastroenteritis
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 65 (4.62%)
         occurrences all number
    3
    3
    stool pattern changes
         subjects affected / exposed
    3 / 62 (4.84%)
    5 / 65 (7.69%)
         occurrences all number
    3
    5
    Vomiting
         subjects affected / exposed
    14 / 62 (22.58%)
    5 / 65 (7.69%)
         occurrences all number
    14
    5
    loss of appetite
         subjects affected / exposed
    15 / 62 (24.19%)
    6 / 65 (9.23%)
         occurrences all number
    15
    6
    Nausea
         subjects affected / exposed
    23 / 62 (37.10%)
    10 / 65 (15.38%)
         occurrences all number
    23
    10
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 62 (8.06%)
    8 / 65 (12.31%)
         occurrences all number
    5
    8
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 62 (12.90%)
    9 / 65 (13.85%)
         occurrences all number
    8
    9
    Skin and subcutaneous tissue disorders
    generalized itching
         subjects affected / exposed
    2 / 62 (3.23%)
    7 / 65 (10.77%)
         occurrences all number
    9
    9
    injection site reactions
         subjects affected / exposed
    26 / 62 (41.94%)
    0 / 65 (0.00%)
         occurrences all number
    26
    0
    Musculoskeletal and connective tissue disorders
    Fatigue
         subjects affected / exposed
    8 / 62 (12.90%)
    3 / 65 (4.62%)
         occurrences all number
    8
    3
    muscle weakness
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Weightloss 0-2 kg
         subjects affected / exposed
    17 / 62 (27.42%)
    13 / 65 (20.00%)
         occurrences all number
    30
    30
    Weightloss 2-4 kg
         subjects affected / exposed
    7 / 62 (11.29%)
    10 / 65 (15.38%)
         occurrences all number
    7
    10
    Weightloss > 4 kg
         subjects affected / exposed
    18 / 62 (29.03%)
    3 / 65 (4.62%)
         occurrences all number
    18
    3

    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.
    It is not possible to repport the findings from the fMRI brain imaging, and DAT SPECT scans, in this format.
    For support, Contact us.
    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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