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    Clinical Trial Results:
    The effectiveness of pharmacological treatment with the glucagon-like peptide-1 receptor agonist Liraglutide 3mg (Saxenda®) once-daily for weight management in forensic psychiatry; An Exploratory pilot study.

    Summary
    EudraCT number
    		 2020-003718-11
    Trial protocol
    		 DK  
    Global end of trial date
    01 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Oct 2023
    First version publication date
    05 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AFJ2020-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04781998
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mental Health Center Copenhagen, Frederiksberg
    Sponsor organisation address
    Hovedvejen 17, Frederiksberg, Denmark, 2000
    Public contact
    Anders Fink-Jensen, Mental Health Center Copenhagen, Frederiksberg, anders.fink-jensen@regionh.dk
    Scientific contact
    Anders Fink-Jensen, Mental Health Center Copenhagen, Frederiksberg, 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
    01 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2022
    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 effectiveness of pharmacological treatment with liraglutide 3 mg (Saxenda®) for bodyweight management in patients with diagnosed with severe mental illness and excess weight (BMI ≥27 kg/m2) who also have bodyweight related medical problems or with severe mental illness and obesity (BMI ≥30 kg/m2), admitted to a forensic psychiatry department. The primary endpoint is the number of patients completing the study defined as “completers”.
    Protection of trial subjects
    The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy restrictions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited by investigators at departments for forensic psychiatry at Mental Health Centre Sct. Hans and Mental Health Centre Glostrup in Denmark

    Pre-assignment
    Screening details
    		 All patients were screened according to in- and exclusion criteria

    Pre-assignment period milestones
    Number of subjects started
    		 24
    Number of subjects completed
    		 24

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

    Arms
    Arm title
    		 Baseline values
    Arm description
    		 Baseline
    Arm type
    		 Baseline

    Investigational medicinal product name
    Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. Initial daily dose is 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached.

    Number of subjects in period 1
    		Baseline values
    Started
    24
    Completed
    24
    Period 2
    Period 2 title
    Overall periode
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. Initial daily dose is 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saxenda 6 mg/ml injektionsvæske, opløsning, i fyldt pen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. Initial daily dose is 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached.

    Number of subjects in period 2
    		Intervention
    Started
    24
    Completed
    11
    Not completed
    13
         Consent withdrawn by subject
    6
         Discharge to another ward/home
    3
         Lost to follow-up
    1
         Coercive measures
    1
         Compliance
    2

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults (18-65 years)
    		 24 24
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Baseline values
    Reporting group description
    		 Baseline
    Reporting group title
    Intervention
    Reporting group description
    		 Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. Initial daily dose is 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached.

    Primary: Number of completers

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    End point title
    		 Number of completers
    End point description
    A “completer” is defined as a participant with adherence to intervention defined as >80% throughout a full study duration (26 weeks)
    End point type
    Primary
    End point timeframe
    Full study duration 26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    24
    11
    Units: subjects
    24
    11
    Statistical analysis title
    		 Categorical endpoint
    Statistical analysis description
    Categorical variables are presented as counts
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    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
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    23
    10
    Units: Kg
        number (not applicable)
    114.1
    96.3
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: HbA1c

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    End point title
    		 HbA1c
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    23
    10
    Units: mmol/mol
        number (not applicable)
    37
    34.5
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    23
    11
    Units: mmHg
        number (not applicable)
    129
    121
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Heart rate

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    End point title
    		 Heart rate
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    23
    11
    Units: beats/minute
        number (not applicable)
    84
    92
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Fibrosis 4 score (FIB-4 score)

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    End point title
    		 Fibrosis 4 score (FIB-4 score)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    20
    8
    Units: NA
        number (not applicable)
    0.9
    1.3
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Cholesterol

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    End point title
    		 Cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    22
    11
    Units: mmol/l
        number (not applicable)
    4.4
    3.8
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Diastolic Blood pressure

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    End point title
    		 Diastolic Blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    23
    11
    Units: mmHg
        number (not applicable)
    83
    80
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: LDL

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    End point title
    		 LDL
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    21
    11
    Units: mmol/l
        number (not applicable)
    2.7
    1.9
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: HDL

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    End point title
    		 HDL
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    22
    11
    Units: mmol/l
        number (not applicable)
    0.9
    1.0
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Secondary: Triglyceride

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    End point title
    		 Triglyceride
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Baseline values Intervention
    Number of subjects analysed
    22
    11
    Units: mmol/l
        number (not applicable)
    1.7
    1.6
    Statistical analysis title
    		 Continuous variables
    Statistical analysis description
    Continuous variables are presented as median. 26-week completion was tested using a binomial test with corresponding confidence intervals and changes in continuous variables were tested using Wilcoxon signed rank test.
    Comparison groups
    Baseline values v Intervention
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    26 weeks (inclusion period). The patients will be informed about the opportunity to contact the investigator group in case of any events or reactions within 10 weeks after termination from the study.
    Adverse event reporting additional description
    Serious adverse events occurring after a subject is discontinued from the study will NOT be reported unless the investigators feel that the event may have been caused by the study drug or a protocol procedure.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention group (all participants)
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention group (all participants)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 24 (12.50%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Psychiatric disorders
    Belt fixation
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fractured hand
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention group (all participants)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 24 (70.83%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Feeling powerless
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Unspecific complains
         subjects affected / exposed
    10 / 24 (41.67%)
         occurrences all number
    10
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    4 / 24 (16.67%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    GERD
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    meteorism
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jun 2022
    Patients receiving treatment with coersive measures were excluded from the trial. The possibility of re-entering the study and continuing study participation by signing a new informed consent after being excluded due to short (less than 48 hours) treatment with coercive measures, was approved in a protocol amendment after study initiation.

    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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