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    Clinical Trial Results:
    An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-005081-22
    Trial protocol
    		 SE   GB  
    Global end of trial date
    26 Aug 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    20 Apr 2023
    First version publication date
    27 Apr 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5670C00022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical Study Information Center
    Sponsor organisation address
    One Medimmune Way, Gaithersburg, United States, 20878
    Public contact
    Medical Monitor, AstraZeneca Clinical Study Information Center, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Medical Monitor, AstraZeneca Clinical Study Information Center, +1 877-240-9479, information.center@astrazeneca.com
    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
    16 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of MEDI0382 on hepatic glycogen levels versus placebo after 28 days (Part A) and 35 days (Part B) of treatment
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
    Background therapy
    		 MEDI0382 is a synthetic peptide with both glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist activity which is under development for the treatment of T2DM and non-alcoholic steatohepatitis (NASH). GLP-1 receptor agonists are established treatments for T2DM that improve glycaemic control, delay gastric emptying, and depress appetite leading to modest, but often non-sustained weight loss (typically 3% versus baseline at one year). Glucagon has similar effects to GLP-1 on gastric emptying and appetite, and has also been shown to promote increased energy expenditure (Lynch et al, 2014; Habegger et al, 2013). Oxyntomodulin, a naturally occurring peptide with GLP-1 and glucagon receptor co-agonist activity, has been shown to promote weight loss through effects on appetite and energy expenditure (Wynne et al, 2006) and co-infusion of GLP-1 and glucagon has synergistic effects on reducing food intake and promoting weight loss in human subjects (Bagger et al, 2015).
    Evidence for comparator
    		 Liraglutide is an analog with 97% homology to human glucagon-like peptide (GLP-1) and acts as a GLP-1 receptor agonist. Several large, randomized, multicenter phase 3 trials evaluated the efficacy and safety of liraglutide by comparing monotherapy and combination therapy with other antidiabetic medications in adult patients with type 2 diabetes. The Liraglutide Effect and Action in Diabetes (LEAD) program demonstrated that liraglutide, when used alone or in combination with other antidiabetic medications, effectively controls hyperglycemia (glycosylated hemoglobin [A1C] reductions up to 1.6%) and assists patients in meeting established glycemic targets. Compared with certain other classes of antidiabetic agents, liraglutide is associated with a lower risk of hypoglycemia. Liraglutide has also been associated with weight loss (1.8 to 3.4 kg) and improved patient satisfaction and health-related quality of life.
    Actual start date of recruitment
    31 May 2018
    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
    Netherlands: 16
    Country: Number of subjects enrolled
    Sweden: 35
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    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)
    21
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 51 participants (total for Part A [21 participants] and B [30 participants]) participated in the study from 31 May 2018 (date first participant enrolled) to 14 April 2021 (date of last participant last visit) at one site in Sweden for Part A, and 2 sites (one in Sweden and one in the Netherlands) for Part B.

    Pre-assignment
    Screening details
    		 A total of 95 participants consented to participate in the study (36 from Part A and 59 from Part B) from one site in Sweden for Part A, and 2 sites (one in Sweden and one in the Netherlands) for Part B. Of these, 15 participants from Part A and 29 participants from Part B were considered screen failures.

    Pre-assignment period milestones
    Number of subjects started
    		 51
    Number of subjects completed
    		 51

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MEDI0382 (Part A)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI0382 100 μg for 7 days, followed by 200 μg for 7 days, followed by 300 μg for 14 days once daily in the morning via SC injection as

    Arm title
    		 Placebo (Part A)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for 28 days

    Arm title
    		 Liraglutide (Part B)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Victoza
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Open label liraglutide 0.6 mg for 7 days, followed by 1.2 mg for 7 days, followed by 1.8 mg for 21 days

    Arm title
    		 MEDI0382 (Part B)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI0382 50 μg for 7 days, followed by 100 μg for 7 days, followed by 200 μg for 7 days, followed by 300 μg for 14 days

    Arm title
    		 Placebo (Part B)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for 35 days

    Number of subjects in period 1
    		MEDI0382 (Part A) Placebo (Part A) Liraglutide (Part B) MEDI0382 (Part B) Placebo (Part B)
    Started
    12
    9
    10
    9
    11
    Completed
    12
    9
    10
    9
    11
    Period 2
    Period 2 title
    Treatment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MEDI0382 (Part A)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI0382 100 μg for 7 days, followed by 200 μg for 7 days, followed by 300 μg for 14 days once daily in the morning via SC injection as

    Arm title
    		 Placebo (Part A)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for 28 days

    Arm title
    		 Liraglutide (Part B)
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Victoza
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Open label liraglutide 0.6 mg for 7 days, followed by 1.2 mg for 7 days, followed by 1.8 mg for 21 days

    Arm title
    		 MEDI0382 (Part B)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MEDI0382 50 μg for 7 days, followed by 100 μg for 7 days, followed by 200 μg for 7 days, followed by 300 μg for 14 days

    Arm title
    		 Placebo (Part B)
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for 35 days

    Number of subjects in period 2
    		MEDI0382 (Part A) Placebo (Part A) Liraglutide (Part B) MEDI0382 (Part B) Placebo (Part B)
    Started
    12
    9
    10
    9
    11
    Completed
    12
    9
    10
    9
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MEDI0382 (Part A)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part A)
    Reporting group description
    		 -

    Reporting group title
    Liraglutide (Part B)
    Reporting group description
    		 -

    Reporting group title
    MEDI0382 (Part B)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part B)
    Reporting group description
    		 -

    Reporting group values
    		 MEDI0382 (Part A) Placebo (Part A) Liraglutide (Part B) MEDI0382 (Part B) Placebo (Part B) Total
    Number of subjects
    		 12 9 10 9 11 51
    Age Categorical
    Units: Subjects
        aged ≥ 18 years
    		 12 9 10 9 11 51
    Gender Categorical
    Units: Subjects
        Female
    		 5 3 4 3 2 17
        Male
    		 7 6 6 6 9 34
    Subject analysis sets

    Subject analysis set title
    As-treated population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who received any study IP were included in the as-treated population and participants were analysed according to the treatment they actually received.

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received any study IP were included in the ITT population and participants were analysed according to their randomised treatment group.

    Subject analysis sets values
    		 As-treated population Intent-to-treat population
    Number of subjects
    51
    51
    Age Categorical
    Units: Subjects
        aged ≥ 18 years
    51
    51
    Age Continuous
    Units:
        
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
    17
    17
        Male
    34
    34

    End points

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    End points reporting groups
    Reporting group title
    MEDI0382 (Part A)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part A)
    Reporting group description
    		 -

    Reporting group title
    Liraglutide (Part B)
    Reporting group description
    		 -

    Reporting group title
    MEDI0382 (Part B)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part B)
    Reporting group description
    		 -
    Reporting group title
    MEDI0382 (Part A)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part A)
    Reporting group description
    		 -

    Reporting group title
    Liraglutide (Part B)
    Reporting group description
    		 -

    Reporting group title
    MEDI0382 (Part B)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part B)
    Reporting group description
    		 -

    Subject analysis set title
    As-treated population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who received any study IP were included in the as-treated population and participants were analysed according to the treatment they actually received.

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received any study IP were included in the ITT population and participants were analysed according to their randomised treatment group.

    Primary: Change in hepatic glycogen concentration adjusted for liver volume as measured by MRS at T = 4 hours post standardised morning meal from baseline (Day -1) to the end of 28 days of treatment (Part A only)

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    End point title
    		 Change in hepatic glycogen concentration adjusted for liver volume as measured by MRS at T = 4 hours post standardised morning meal from baseline (Day -1) to the end of 28 days of treatment (Part A only)
    End point description
    To assess the effect of cotadutide on hepatic glycogen levels versus placebo after 28 days (Part A)
    End point type
    Primary
    End point timeframe
    from baseline (Day -1) to the end of 28 days of treatment (Part A only)
    End point values
    		 MEDI0382 (Part A) Placebo (Part A) Intent-to-treat population
    Number of subjects analysed
    12
    9
    21 [1]
    Units: mmol/L
    least squares mean (confidence interval 90%)
        Change from baseline
    -100.2 (-150.2 to -50.1)
    5.5 (-47.2 to 58.3)
    -105.7 (-178.8 to -32.6)
    Notes
    [1] - Part A Only MEDI0382 (Part A) vs. Placebo (Part A)
    Statistical analysis title
    		 Primary Analysis (Part A)
    Statistical analysis description
    To assess the effect of cotadutide on hepatic glycogen levels versus placebo after 28 days (Part A)
    Comparison groups
    MEDI0382 (Part A) v Placebo (Part A)
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -105.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -178.8
         upper limit
    		 -32.6

    Primary: Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS at T = 24 hours post standardised morning meal from baseline (Day 1) to the end of 35 days of treatment (Day 36) (Part B)

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    End point title
    		 Percentage change in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS at T = 24 hours post standardised morning meal from baseline (Day 1) to the end of 35 days of treatment (Day 36) (Part B)
    End point description
    End point type
    Primary
    End point timeframe
    from baseline (Day 1) to the end of 35 days of treatment (Day 36) (Part B)
    End point values
    		 MEDI0382 (Part B) Placebo (Part B) Intent-to-treat population
    Number of subjects analysed
    9
    11
    20 [2]
    Units: percent change from baseline
        least squares mean (confidence interval 90%)
    -27.02 (-38.04 to -16.01)
    -1.15 (-11.09 to 8.79)
    -25.87 (-40.88 to -10.86)
    Notes
    [2] - Part B Only MEDI0382 (Part B) vs. Placebo (Part B)
    Statistical analysis title
    		 Primary Analysis Part B
    Statistical analysis description
    To assess the effect of cotadutide on hepatic glycogen levels versus placebo after 35 days (Part B) of treatment
    Comparison groups
    MEDI0382 (Part B) v Placebo (Part B) v Intent-to-treat population
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -25.87
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -40.88
         upper limit
    		 -10.86

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Adverse event reporting additional description
    Adverse events were coded with MedDRA version 21.0 or higher. Analysis of AEs included the type, incidence, severity and relationship to study IP summarised by MedDRA SOC and PT by study part treatment group as well as for combined study parts.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    MEDI0382 (Part A)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part A)
    Reporting group description
    		 -

    Reporting group title
    Liraglutide (Part B)
    Reporting group description
    		 -

    Reporting group title
    MEDI0382 (Part B)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Part B)
    Reporting group description
    		 -

    Serious adverse events
    		 MEDI0382 (Part A) Placebo (Part A) Liraglutide (Part B) MEDI0382 (Part B) Placebo (Part B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MEDI0382 (Part A) Placebo (Part A) Liraglutide (Part B) MEDI0382 (Part B) Placebo (Part B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    7 / 9 (77.78%)
    8 / 10 (80.00%)
    7 / 9 (77.78%)
    6 / 11 (54.55%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Chills
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    1
    0
    0
    Early satiety
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    6 / 12 (50.00%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
    3 / 9 (33.33%)
    0 / 11 (0.00%)
         occurrences all number
    7
    2
    1
    3
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site rash
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    2
    3
    0
    1
    0
    Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dry throat
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rhinalgia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Psychiatric disorders
    Apathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Daydreaming
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Investigations
    Heart rate increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 12 (41.67%)
    3 / 9 (33.33%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    11
    3
    3
    1
    2
    Dizziness
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    3
    0
    2
    1
    1
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    5
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
         occurrences all number
    0
    4
    0
    2
    1
    Dry mouth
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
         occurrences all number
    3
    0
    2
    2
    0
    Breath odour
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    5 / 12 (41.67%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    8
    1
    1
    3
    0
    Dyspepsia
         subjects affected / exposed
    6 / 12 (50.00%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    10
    3
    2
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Nausea
         subjects affected / exposed
    8 / 12 (66.67%)
    2 / 9 (22.22%)
    1 / 10 (10.00%)
    5 / 9 (55.56%)
    0 / 11 (0.00%)
         occurrences all number
    11
    4
    3
    7
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Torticollis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Otitis media acute
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 9 (11.11%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    1
    2
    0
    0
    Food craving
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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