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    Clinical Trial Results:
    A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects

    Summary
    EudraCT number
    2017-003616-39
    Trial protocol
    SE   BE   PL  
    Global end of trial date
    08 Mar 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR108314
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03486392
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    08 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the effects of JNJ-64565111 compared with placebo in non-diabetic severely obese subjects after 26 Weeks of treatment on the percentage change from baseline in body weight and safety and tolerability.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was evaluated throughout the study and included monitoring of adverse events (AEs), vital sign measurements, clinical laboratory tests (including calcitonin, lipase, amylase, alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin, and sodium), urinalysis, review of concomitant medications, and pregnancy testing.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Mar 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
    Sweden: 81
    Country: Number of subjects enrolled
    United Kingdom: 58
    Country: Number of subjects enrolled
    United States: 154
    Country: Number of subjects enrolled
    Belgium: 58
    Country: Number of subjects enrolled
    Canada: 62
    Country: Number of subjects enrolled
    Poland: 61
    Worldwide total number of subjects
    474
    EEA total number of subjects
    258
    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)
    448
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 474 subjects were randomized out of which 444 subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double Blind: Placebo
    Arm description
    Subjects self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered the matching placebo of JNJ-64565111 SC once-weekly.

    Arm title
    Double Blind: JNJ-64565111 5.0 mg
    Arm description
    Subjects self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-64565111 5.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered 5.0 mg JNJ-64565111 SC once-weekly.

    Arm title
    Double Blind: JNJ-64565111 7.4 mg
    Arm description
    Subjects self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-64565111 7.4 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered 7.4 mg JNJ-64565111 SC once-weekly.

    Arm title
    Double Blind: JNJ-64565111 10.0 mg
    Arm description
    Subjects self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-64565111 10.0 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered 10.0 mg JNJ-64565111 SC once-weekly.

    Arm title
    Open Label: Liraglutide 3.0 mg
    Arm description
    Subjects self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Subjects then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
    Arm type
    Active comparator

    Investigational medicinal product name
    Liraglutide 3.0 mg
    Investigational medicinal product code
    Other name
    Saxenda
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5).

    Number of subjects in period 1
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Started
    60
    59
    118
    118
    119
    Completed
    57
    59
    104
    109
    115
    Not completed
    3
    0
    14
    9
    4
         Death
    -
    -
    -
    -
    1
         Consent withdrawn by subject
    3
    -
    6
    4
    1
         Lost to follow-up
    -
    -
    8
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double Blind: Placebo
    Reporting group description
    Subjects self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 5.0 mg
    Reporting group description
    Subjects self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 7.4 mg
    Reporting group description
    Subjects self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 10.0 mg
    Reporting group description
    Subjects self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Open Label: Liraglutide 3.0 mg
    Reporting group description
    Subjects self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Subjects then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.

    Reporting group values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg Total
    Number of subjects
    60 59 118 118 119 474
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    56 57 111 113 111 448
        From 65 to 84 years
    4 2 7 5 8 26
        85 years and over
    0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    46.9 ± 11.84 47.3 ± 11.18 46.2 ± 11.68 46.2 ± 12.16 45.6 ± 11.71 -
    Title for Gender
    Units: subjects
        Female
    48 47 86 86 89 356
        Male
    12 12 32 32 30 118

    End points

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    End points reporting groups
    Reporting group title
    Double Blind: Placebo
    Reporting group description
    Subjects self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 5.0 mg
    Reporting group description
    Subjects self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 7.4 mg
    Reporting group description
    Subjects self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 10.0 mg
    Reporting group description
    Subjects self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Open Label: Liraglutide 3.0 mg
    Reporting group description
    Subjects self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Subjects then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.

    Primary: Percent Change From Baseline in Body Weight at Week 26

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    End point title
    Percent Change From Baseline in Body Weight at Week 26
    End point description
    Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported. Modified intent-to-treat (mITT) population included all ITT subjects who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    End point values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Number of subjects analysed
    60
    58
    109
    109
    108
    Units: Percent Change
        least squares mean (standard error)
    -1.76 ± 0.73
    -8.51 ± 0.76
    -9.83 ± 0.56
    -11.80 ± 0.58
    -7.54 ± 0.54
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Double Blind: Placebo v Double Blind: JNJ-64565111 5.0 mg
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Dunnett’s method
    Parameter type
    Difference of least square (LS) Means
    Point estimate
    -6.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.31
         upper limit
    -4.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.056
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Double Blind: Placebo v Double Blind: JNJ-64565111 7.4 mg
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Dunnett’s method
    Parameter type
    Difference of LS Means
    Point estimate
    -8.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.31
         upper limit
    -5.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.921
    Statistical analysis title
    Statistical Analysis 3
    Comparison groups
    Double Blind: Placebo v Double Blind: JNJ-64565111 10.0 mg
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Dunnett’s method
    Parameter type
    Difference of LS Means
    Point estimate
    -10.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.31
         upper limit
    -7.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.934
    Statistical analysis title
    Statistical Analysis 4
    Comparison groups
    Double Blind: Placebo v Open Label: Liraglutide 3.0 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Dunnett’s method
    Parameter type
    Difference of LS Means
    Point estimate
    -5.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.99
         upper limit
    -3.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.91

    Primary: Number of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    Number of Subjects with Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide subjects, and plus 35 days for JNJ-64565111 and placebo subjects. Safety analysis set included all randomized subjects who had received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Week 30
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Number of subjects analysed
    60
    59
    118
    118
    119
    Units: Subjects
    43
    53
    110
    110
    96
    No statistical analyses for this end point

    Secondary: Number of Subjects with Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

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    End point title
    Number of Subjects with Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
    End point description
    Number of subjects with >= 5% body weight loss from baseline to Week 26 were reported. mITT population included all ITT subjects who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Number of subjects analysed
    60
    59
    116
    116
    109
    Units: Subjects
    8
    34
    70
    62
    56
    No statistical analyses for this end point

    Secondary: Number of Subjects with Greater Than or Equal to 10 % Body Weight Loss at Week 26

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    End point title
    Number of Subjects with Greater Than or Equal to 10 % Body Weight Loss at Week 26
    End point description
    Number of subjects with >= 10 % body weight loss from baseline to Week 26 were reported. mITT population included all ITT subjects who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Number of subjects analysed
    60
    59
    116
    116
    109
    Units: Subjects
    2
    23
    43
    46
    27
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Weight at Week 26

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    End point title
    Change From Baseline in Body Weight at Week 26
    End point description
    Change from baseline in body weight at Week 26 was reported. mITT population included all ITT subjects who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
    Number of subjects analysed
    60
    58
    109
    109
    108
    Units: kg
        least squares mean (standard error)
    -2.05 ± 0.827
    -9.58 ± 0.861
    -11.07 ± 0.633
    -13.23 ± 0.656
    -8.32 ± 0.610
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 Weeks
    Adverse event reporting additional description
    Safety analysis set included all randomized participants who had received at least one dose of study drug.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Double Blind: Placebo
    Reporting group description
    Subjects self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 5.0 mg
    Reporting group description
    Subjects self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 7.4 mg
    Reporting group description
    Subjects self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Double Blind: JNJ-64565111 10.0 mg
    Reporting group description
    Subjects self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.

    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    Subjects self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Subjects then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.

    Serious adverse events
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Liraglutide 3.0 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 59 (5.08%)
    2 / 118 (1.69%)
    4 / 118 (3.39%)
    4 / 119 (3.36%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Stress Cardiomyopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 118 (0.85%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 118 (0.85%)
    2 / 118 (1.69%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary Colic
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    0 / 118 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 118 (0.00%)
    1 / 118 (0.85%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Liraglutide 3.0 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 60 (55.00%)
    43 / 59 (72.88%)
    106 / 118 (89.83%)
    104 / 118 (88.14%)
    81 / 119 (68.07%)
    Investigations
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 118 (1.69%)
    6 / 118 (5.08%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    6
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 59 (6.78%)
    3 / 118 (2.54%)
    2 / 118 (1.69%)
    0 / 119 (0.00%)
         occurrences all number
    1
    4
    3
    2
    0
    Headache
         subjects affected / exposed
    6 / 60 (10.00%)
    7 / 59 (11.86%)
    20 / 118 (16.95%)
    8 / 118 (6.78%)
    9 / 119 (7.56%)
         occurrences all number
    10
    10
    31
    9
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 60 (3.33%)
    7 / 59 (11.86%)
    15 / 118 (12.71%)
    17 / 118 (14.41%)
    5 / 119 (4.20%)
         occurrences all number
    2
    7
    20
    17
    6
    Injection Site Bruising
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 59 (3.39%)
    1 / 118 (0.85%)
    2 / 118 (1.69%)
    1 / 119 (0.84%)
         occurrences all number
    5
    2
    1
    2
    2
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 59 (5.08%)
    0 / 118 (0.00%)
    3 / 118 (2.54%)
    1 / 119 (0.84%)
         occurrences all number
    1
    3
    0
    3
    1
    Abdominal Distension
         subjects affected / exposed
    2 / 60 (3.33%)
    4 / 59 (6.78%)
    6 / 118 (5.08%)
    6 / 118 (5.08%)
    7 / 119 (5.88%)
         occurrences all number
    2
    4
    6
    7
    9
    Abdominal Pain
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    8 / 118 (6.78%)
    4 / 118 (3.39%)
    3 / 119 (2.52%)
         occurrences all number
    1
    2
    8
    5
    3
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 59 (3.39%)
    10 / 118 (8.47%)
    3 / 118 (2.54%)
    8 / 119 (6.72%)
         occurrences all number
    2
    2
    10
    3
    8
    Constipation
         subjects affected / exposed
    3 / 60 (5.00%)
    7 / 59 (11.86%)
    20 / 118 (16.95%)
    21 / 118 (17.80%)
    20 / 119 (16.81%)
         occurrences all number
    5
    9
    23
    26
    24
    Diarrhoea
         subjects affected / exposed
    3 / 60 (5.00%)
    8 / 59 (13.56%)
    24 / 118 (20.34%)
    23 / 118 (19.49%)
    27 / 119 (22.69%)
         occurrences all number
    5
    14
    32
    37
    36
    Dry Mouth
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 59 (6.78%)
    6 / 118 (5.08%)
    5 / 118 (4.24%)
    3 / 119 (2.52%)
         occurrences all number
    1
    4
    10
    5
    3
    Dyspepsia
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 59 (8.47%)
    18 / 118 (15.25%)
    13 / 118 (11.02%)
    9 / 119 (7.56%)
         occurrences all number
    2
    5
    19
    15
    9
    Eructation
         subjects affected / exposed
    0 / 60 (0.00%)
    4 / 59 (6.78%)
    14 / 118 (11.86%)
    16 / 118 (13.56%)
    5 / 119 (4.20%)
         occurrences all number
    0
    4
    15
    36
    5
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 59 (8.47%)
    13 / 118 (11.02%)
    12 / 118 (10.17%)
    9 / 119 (7.56%)
         occurrences all number
    1
    5
    13
    14
    12
    Nausea
         subjects affected / exposed
    4 / 60 (6.67%)
    30 / 59 (50.85%)
    80 / 118 (67.80%)
    79 / 118 (66.95%)
    48 / 119 (40.34%)
         occurrences all number
    6
    42
    181
    146
    74
    Vomiting
         subjects affected / exposed
    0 / 60 (0.00%)
    12 / 59 (20.34%)
    47 / 118 (39.83%)
    65 / 118 (55.08%)
    20 / 119 (16.81%)
         occurrences all number
    0
    18
    118
    108
    38
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 60 (1.67%)
    10 / 59 (16.95%)
    16 / 118 (13.56%)
    20 / 118 (16.95%)
    10 / 119 (8.40%)
         occurrences all number
    1
    10
    18
    20
    11
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    1 / 118 (0.85%)
    1 / 118 (0.85%)
    1 / 119 (0.84%)
         occurrences all number
    3
    1
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    9 / 60 (15.00%)
    5 / 59 (8.47%)
    11 / 118 (9.32%)
    6 / 118 (5.08%)
    10 / 119 (8.40%)
         occurrences all number
    13
    5
    11
    10
    10
    Pharyngitis
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    2 / 118 (1.69%)
    0 / 118 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    3
    0
    2
    0
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    4 / 118 (3.39%)
    2 / 118 (1.69%)
    6 / 119 (5.04%)
         occurrences all number
    4
    0
    5
    3
    6
    Urinary Tract Infection
         subjects affected / exposed
    3 / 60 (5.00%)
    4 / 59 (6.78%)
    10 / 118 (8.47%)
    7 / 118 (5.93%)
    5 / 119 (4.20%)
         occurrences all number
    3
    4
    12
    9
    5

    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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