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    Clinical Trial Results:
    A 20-week, double blind, randomized, placebo controlled, parallel group trial to assess the safety and efficacy of HM11260C on body weight in obese subjects without diabetes

    Summary
    EudraCT number
    2013-004251-21
    Trial protocol
    DE   HU   NL  
    Global end of trial date
    17 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Nov 2016
    First version publication date
    06 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HM-EXC-205
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02075281
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Hanmi Pharmaceutical Co., Ltd.
    Sponsor organisation address
    14, Wiryeseong-daero, Songpa-gu, Seoul, Korea, Republic of, 05545
    Public contact
    Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd., +82 2-410-9041, jhkang@hanmi.co.kr
    Scientific contact
    Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd., +82 2-410-9041, jhkang@hanmi.co.kr
    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
    25 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of HM11260C, in combination with a hypocaloric diet, on body weight over the 20 weeks from baseline in obese subjects.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with ICH GCP ensuring that those involved with the conduct of the study abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Apr 2014
    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
    Korea, Republic of: 24
    Country: Number of subjects enrolled
    United States: 216
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    Hungary: 3
    Worldwide total number of subjects
    297
    EEA total number of subjects
    57
    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)
    297
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment period from 09Apr2014 (First patient screened)/23Apr2014 (First patient randomized) to 25Jul2014 (Last Patient screened)/19Aug2014 (Last Patient randomized). Regions: USA, Europe (Germany, Hungary, Netherlands) and Asia (South Korea)

    Pre-assignment
    Screening details
    Study design: 4 weeks screening period, then 2 weeks titration period, 18 weeks treatment period and 6 weeks follow-up period. 509 subjects screened.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    HM11260C and placebo for HM11260C were provided in identically matched prefilled syringe and packaged identically.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    HM11260C (4 mg QW)
    Arm description
    subcutaneous (sc) HM11260C 4 mg once a week (QW) for 20 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.8 ml of HM11260C (5.0 mg/ml concentration) was self administered by subcutaneous injection in the morning before the meal using prefilled syringe.

    Arm title
    HM11260C (6 mg QW)
    Arm description
    subcutaneous (sc) HM11260C 6 mg once a week (QW) for 20 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.8 ml of HM11260C (7.5 mg/ml concentration) was self administered by subcutaneous injection in the morning before the meal using prefilled syringe.

    Arm title
    HM11260C (6 mg Q2W)
    Arm description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 6 mg was administered on day 8, and then 6 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses
    Arm type
    Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.8 ml of HM11260C (7.5 mg/ml concentration) was self administered by subcutaneous injection in the morning before the meal using prefilled syringe.

    Arm title
    HM11260C (8 mg Q2W)
    Arm description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 8 mg was administered on day 8, then 8 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses
    Arm type
    Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.8 ml of HM11260C (10.0 mg/ml concentration) was self administered by subcutaneous injection in the morning before the meal using prefilled syringe.

    Arm title
    Placebo
    Arm description
    subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 20 weeks
    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
    0.8 ml of Placebo was self administered by subcutaneous injection in the morning before the meal using prefilled syringe.

    Number of subjects in period 1 [1]
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Started
    59
    59
    59
    58
    60
    Completed
    44
    43
    41
    40
    48
    Not completed
    15
    16
    18
    18
    12
         Protocol deviation
    -
    -
    -
    -
    1
         Other
    4
    -
    1
    -
    1
         Noncompliance
    -
    -
    2
    -
    1
         Clinically Significant Lab Abnormalities
    -
    -
    1
    1
    -
         Withdrawal by subject
    5
    4
    4
    6
    4
         Prohibited Treatment
    1
    -
    1
    -
    -
         Adverse event, non-fatal
    3
    11
    7
    11
    3
         Lost to follow-up
    2
    1
    2
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 297 subjects were enrolled and randomized into the study. A total of 295 subjects received study drug (HM11260C or placebo) and were included in the Safety Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HM11260C (4 mg QW)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg once a week (QW) for 20 weeks

    Reporting group title
    HM11260C (6 mg QW)
    Reporting group description
    subcutaneous (sc) HM11260C 6 mg once a week (QW) for 20 weeks

    Reporting group title
    HM11260C (6 mg Q2W)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 6 mg was administered on day 8, and then 6 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses

    Reporting group title
    HM11260C (8 mg Q2W)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 8 mg was administered on day 8, then 8 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses

    Reporting group title
    Placebo
    Reporting group description
    subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 20 weeks

    Reporting group values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo Total
    Number of subjects
    59 59 59 58 60 295
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.9 ± 12.14 43 ± 13.02 43.3 ± 12.45 43.9 ± 9.16 43.7 ± 11.84 -
    Gender categorical
    Units: Subjects
        Female
    41 46 43 51 44 225
        Male
    18 13 16 7 16 70

    End points

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    End points reporting groups
    Reporting group title
    HM11260C (4 mg QW)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg once a week (QW) for 20 weeks

    Reporting group title
    HM11260C (6 mg QW)
    Reporting group description
    subcutaneous (sc) HM11260C 6 mg once a week (QW) for 20 weeks

    Reporting group title
    HM11260C (6 mg Q2W)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 6 mg was administered on day 8, and then 6 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses

    Reporting group title
    HM11260C (8 mg Q2W)
    Reporting group description
    subcutaneous (sc) HM11260C 4 mg was administered on day 1, then 8 mg was administered on day 8, then 8 mg once every two weeks (Q2W) for 18 weeks, with placebo administered once every 2 weeks between HM11260C doses

    Reporting group title
    Placebo
    Reporting group description
    subcutaneous (sc) Placebo identical to HM11260C once a week (QW) for 20 weeks

    Primary: Change from Baseline in Body Weight for HM11260C

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    End point title
    Change from Baseline in Body Weight for HM11260C
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). Full Analysis Set (FAS) population: all participants who received study drug and had at least 1 efficacy or safety assessment recorded after dosing.
    End point type
    Primary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    49
    59
    59
    58
    60
    Units: kg
        least squares mean (standard error)
    -6.63 ± 0.621
    -7.32 ± 0.627
    -6.4 ± 0.626
    -7.06 ± 0.635
    -0.13 ± 0.605
    Statistical analysis title
    Change in Body Weight for 4 mg QW vs placebo
    Comparison groups
    HM11260C (4 mg QW) v Placebo
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.0001
    Method
    Mixed Model Repeated Measures
    Parameter type
    LS Mean Difference
    Point estimate
    -6.5
    Confidence interval
         level
    95.1%
         sides
    2-sided
         lower limit
    -8.22
         upper limit
    -4.79
    Variability estimate
    Standard error of the mean
    Notes
    [1] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Statistical analysis title
    Change in Body Weight for 6 mg QW vs placebo
    Statistical analysis description
    Superiority for HM11260C 6 mg QW vs placebo, the threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Comparison groups
    HM11260C (6 mg QW) v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.0001
    Method
    Mixed Model Repeated Measures
    Parameter type
    LS Mean Difference
    Point estimate
    -7.2
    Confidence interval
         level
    95.1%
         sides
    2-sided
         lower limit
    -8.92
         upper limit
    -5.47
    Variability estimate
    Standard error of the mean
    Notes
    [2] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Statistical analysis title
    Change in Body Weight for 6 mg Q2W vs placebo
    Comparison groups
    HM11260C (6 mg Q2W) v Placebo
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.0001
    Method
    Mixed Model Repeated Measures
    Parameter type
    LS Mean Difference
    Point estimate
    -6.28
    Confidence interval
         level
    95.1%
         sides
    2-sided
         lower limit
    -8
         upper limit
    -4.56
    Variability estimate
    Standard error of the mean
    Notes
    [3] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Statistical analysis title
    Change in Body Weight for 8 mg Q2W vs placebo
    Comparison groups
    HM11260C (8 mg Q2W) v Placebo
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    Method
    Mixed Model Repeated Measures
    Parameter type
    LS Mean Difference
    Point estimate
    -6.93
    Confidence interval
         level
    95.1%
         sides
    2-sided
         lower limit
    -8.67
         upper limit
    -5.2
    Variability estimate
    Standard error of the mean
    Notes
    [4] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

    Secondary: Change from Baseline in Glucose Metabolism Parameters (Fasting Plasma Glucose)

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    End point title
    Change from Baseline in Glucose Metabolism Parameters (Fasting Plasma Glucose)
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    59
    59
    59
    58
    60
    Units: mmol/L
        least squares mean (standard error)
    -0.311 ± 0.0836
    -0.428 ± 0.0854
    -0.497 ± 0.088
    -0.515 ± 0.0882
    0.056 ± 0.081
    No statistical analyses for this end point

    Secondary: Change from Baseline in Glucose Metabolism Parameters (HbA1c)

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    End point title
    Change from Baseline in Glucose Metabolism Parameters (HbA1c)
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    59
    59
    59
    58
    60
    Units: Percentage
        least squares mean (standard error)
    -0.24 ± 0.029
    -0.29 ± 0.03
    -0.29 ± 0.03
    -0.3 ± 0.03
    0.05 ± 0.027
    No statistical analyses for this end point

    Secondary: Change from Baseline in Glucose Metabolism Parameters (Fasting Insulin)

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    End point title
    Change from Baseline in Glucose Metabolism Parameters (Fasting Insulin)
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    59
    59
    59
    58
    60
    Units: pmol/L
        least squares mean (standard error)
    -0.24 ± 13.137
    -21.7 ± 13.341
    1.79 ± 13.598
    -12.19 ± 13.563
    18.33 ± 12.763
    No statistical analyses for this end point

    Secondary: Change from Baseline in Glucose Metabolism Parameters (C-Peptide)

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    End point title
    Change from Baseline in Glucose Metabolism Parameters (C-Peptide)
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    59
    59
    59
    58
    60
    Units: nmol/L
        least squares mean (standard error)
    -0.011 ± 0.0213
    -0.049 ± 0.0216
    0.016 ± 0.022
    0.002 ± 0.0219
    -0.014 ± 0.0207
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Lipid Profile Parameters (Total Cholesterol, LDL-C)

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    End point title
    Change from Baseline in Serum Lipid Profile Parameters (Total Cholesterol, LDL-C)
    End point description
    Least squares (LS) means and standard errors at Week 21 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 21
    End point values
    HM11260C (4 mg QW) HM11260C (6 mg QW) HM11260C (6 mg Q2W) HM11260C (8 mg Q2W) Placebo
    Number of subjects analysed
    59
    59
    59
    58
    60
    Units: mmol/L
    least squares mean (standard error)
        Total Cholesterol
    -0.23 ± 0.082
    -0.32 ± 0.083
    -0.27 ± 0.084
    -0.23 ± 0.086
    0.11 ± 0.079
        LDL-C
    0 ± 0.075
    -0.1 ± 0.077
    0.01 ± 0.078
    0 ± 0.079
    0.26 ± 0.073
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected beginning at screening and continuing through the final patient visit. SAEs, regardless of suspected causality, were recorded until at least 45 days after the subject had received last dose of study drug.
    Adverse event reporting additional description
    Reported AEs were TEAEs that had a start date on or after the first dose of IP or, if the start date was before the date of the first dose of IP, increased in severity on or after the date of the first dose of IP. Treatment-emergent SAEs and TEAEs were reported for the Safety Set, consisting of all participants who received any study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    HM11260C (4mg QW)
    Reporting group description
    Subjects received HM11260C 4mg as a weekly subcutaneous injection in the abdomen via a pre-filled syringe.

    Reporting group title
    HM11260C (6mg QW)
    Reporting group description
    Subjects received HM11260C 6mg as a weekly subcutaneous injection in the abdomen via a pre-filled syringe.

    Reporting group title
    HM11260C (6mg Q2W)
    Reporting group description
    Subjects received a weekly subcutaneous injection in the abdomen via a pre-filled syringe. HM11260C 4mg was administered on Day 1, HM11260C 6mg was administered on Day 8, and thereafter HM11260C 6 mg was administered every 14 days, with placebo between HM11260C doses.

    Reporting group title
    HM11260C (8mg Q2W)
    Reporting group description
    Subjects received a weekly subcutaneous injection in the abdomen via a pre-filled syringe. HM11260C 4mg was administered on Day 1, HM11260C 8mg was administered on Day 8, and thereafter HM11260C 8 mg was administered every 14 days, with placebo between HM11260C doses.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo as a weekly subcutaneous injection in the abdomen via a pre-filled syringe.

    Serious adverse events
    HM11260C (4mg QW) HM11260C (6mg QW) HM11260C (6mg Q2W) HM11260C (8mg Q2W) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 59 (1.69%)
    3 / 59 (5.08%)
    0 / 59 (0.00%)
    2 / 58 (3.45%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (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
    Nausea
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (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
    Vomiting
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (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
    Cholelithiasis
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (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
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    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 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    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
    Erysipelas
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (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
    Diverticulitis
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (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
    HM11260C (4mg QW) HM11260C (6mg QW) HM11260C (6mg Q2W) HM11260C (8mg Q2W) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 59 (86.44%)
    54 / 59 (91.53%)
    51 / 59 (86.44%)
    51 / 58 (87.93%)
    48 / 60 (80.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    0
    2
    3
    Investigations
    Lipase increased
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    3 / 58 (5.17%)
    2 / 60 (3.33%)
         occurrences all number
    4
    1
    1
    3
    2
    Heart rate increased
         subjects affected / exposed
    0 / 59 (0.00%)
    3 / 59 (5.08%)
    1 / 59 (1.69%)
    1 / 58 (1.72%)
    1 / 60 (1.67%)
         occurrences all number
    0
    3
    1
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 59 (1.69%)
    4 / 59 (6.78%)
    1 / 58 (1.72%)
    2 / 60 (3.33%)
         occurrences all number
    2
    1
    4
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    2 / 58 (3.45%)
    5 / 60 (8.33%)
         occurrences all number
    1
    0
    1
    2
    5
    Nasal congestion
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    0 / 58 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    0
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 59 (18.64%)
    15 / 59 (25.42%)
    8 / 59 (13.56%)
    15 / 58 (25.86%)
    10 / 60 (16.67%)
         occurrences all number
    16
    19
    18
    24
    16
    Dizziness
         subjects affected / exposed
    8 / 59 (13.56%)
    3 / 59 (5.08%)
    7 / 59 (11.86%)
    7 / 58 (12.07%)
    5 / 60 (8.33%)
         occurrences all number
    14
    3
    8
    11
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 59 (15.25%)
    3 / 59 (5.08%)
    5 / 59 (8.47%)
    8 / 58 (13.79%)
    7 / 60 (11.67%)
         occurrences all number
    10
    3
    6
    8
    7
    Injection site pain
         subjects affected / exposed
    6 / 59 (10.17%)
    5 / 59 (8.47%)
    3 / 59 (5.08%)
    4 / 58 (6.90%)
    5 / 60 (8.33%)
         occurrences all number
    30
    11
    3
    6
    5
    Injection site erythema
         subjects affected / exposed
    5 / 59 (8.47%)
    2 / 59 (3.39%)
    1 / 59 (1.69%)
    2 / 58 (3.45%)
    1 / 60 (1.67%)
         occurrences all number
    17
    4
    1
    2
    1
    Injection site bruising
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    3
    2
    1
    1
    4
    Pyrexia
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    2 / 59 (3.39%)
    0 / 58 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    2
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    14 / 59 (23.73%)
    12 / 59 (20.34%)
    15 / 59 (25.42%)
    16 / 58 (27.59%)
    12 / 60 (20.00%)
         occurrences all number
    20
    17
    34
    36
    23
    Dyspepsia
         subjects affected / exposed
    12 / 59 (20.34%)
    16 / 59 (27.12%)
    9 / 59 (15.25%)
    15 / 58 (25.86%)
    2 / 60 (3.33%)
         occurrences all number
    47
    25
    13
    20
    2
    Constipation
         subjects affected / exposed
    10 / 59 (16.95%)
    12 / 59 (20.34%)
    9 / 59 (15.25%)
    12 / 58 (20.69%)
    5 / 60 (8.33%)
         occurrences all number
    17
    15
    17
    19
    5
    Abdominal pain upper
         subjects affected / exposed
    3 / 59 (5.08%)
    6 / 59 (10.17%)
    5 / 59 (8.47%)
    9 / 58 (15.52%)
    3 / 60 (5.00%)
         occurrences all number
    6
    6
    8
    17
    9
    Abdominal distension
         subjects affected / exposed
    4 / 59 (6.78%)
    5 / 59 (8.47%)
    2 / 59 (3.39%)
    8 / 58 (13.79%)
    1 / 60 (1.67%)
         occurrences all number
    4
    7
    2
    9
    1
    Flatulence
         subjects affected / exposed
    3 / 59 (5.08%)
    3 / 59 (5.08%)
    3 / 59 (5.08%)
    6 / 58 (10.34%)
    1 / 60 (1.67%)
         occurrences all number
    3
    4
    3
    6
    4
    Eructation
         subjects affected / exposed
    1 / 59 (1.69%)
    5 / 59 (8.47%)
    2 / 59 (3.39%)
    5 / 58 (8.62%)
    0 / 60 (0.00%)
         occurrences all number
    1
    5
    4
    8
    0
    Abdominal discomfort
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 59 (3.39%)
    3 / 59 (5.08%)
    3 / 58 (5.17%)
    1 / 60 (1.67%)
         occurrences all number
    2
    2
    4
    3
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 59 (3.39%)
    0 / 59 (0.00%)
    3 / 58 (5.17%)
    2 / 60 (3.33%)
         occurrences all number
    4
    2
    0
    4
    3
    Dry mouth
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    3 / 59 (5.08%)
    3 / 58 (5.17%)
    2 / 60 (3.33%)
         occurrences all number
    0
    1
    3
    3
    2
    Abdominal pain lower
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    2 / 59 (3.39%)
    3 / 58 (5.17%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    2
    3
    3
    Nausea
         subjects affected / exposed
    32 / 59 (54.24%)
    34 / 59 (57.63%)
    28 / 59 (47.46%)
    36 / 58 (62.07%)
    11 / 60 (18.33%)
         occurrences all number
    88
    74
    70
    117
    14
    Vomiting
         subjects affected / exposed
    13 / 59 (22.03%)
    12 / 59 (20.34%)
    10 / 59 (16.95%)
    19 / 58 (32.76%)
    4 / 60 (6.67%)
         occurrences all number
    18
    36
    16
    28
    4
    Abdominal pain
         subjects affected / exposed
    3 / 59 (5.08%)
    10 / 59 (16.95%)
    2 / 59 (3.39%)
    8 / 58 (13.79%)
    2 / 60 (3.33%)
         occurrences all number
    3
    15
    3
    15
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 59 (5.08%)
    4 / 59 (6.78%)
    0 / 59 (0.00%)
    5 / 58 (8.62%)
    4 / 60 (6.67%)
         occurrences all number
    3
    5
    0
    7
    4
    Myalgia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    0
    1
    2
    1
    3
    Joint crepitation
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    0 / 58 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    1
    1
    0
    4
    Arthralgia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    0
    1
    0
    1
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 59 (11.86%)
    4 / 59 (6.78%)
    5 / 59 (8.47%)
    5 / 58 (8.62%)
    5 / 60 (8.33%)
         occurrences all number
    8
    5
    6
    6
    7
    Nasopharyngitis
         subjects affected / exposed
    5 / 59 (8.47%)
    4 / 59 (6.78%)
    1 / 59 (1.69%)
    3 / 58 (5.17%)
    8 / 60 (13.33%)
         occurrences all number
    6
    4
    1
    3
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2013
    Version 2 The protocol amendment was undertaken primarily for modifying inclusion and exclusion criteria and other sections.
    25 Apr 2014
    Version 3 The protocol amendment was undertaken primarily for updating the contraception inclusion criterion for females of child-bearing potential and males and exclusion criterion.
    10 Dec 2014
    Version 4 This amendment was due to glucagon assay. Glucagon assessments and analyses were removed from the study as the glucagon assay performed during the study up to that time was not sensitive enough and did not give results within the normal range for glucagon.

    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.
    Per global protocol amendment #3, 10-Dec-2014 glucagon secondary objective and assessment were both removed as the assay was not sensitive enough and did not give results within the normal range for glucagon.
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