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    Clinical Trial Results:
    A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

    Summary
    EudraCT number
    		 2011-006062-40
    Trial protocol
    		 DE   SE  
    Global end of trial date
    12 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2018
    First version publication date
    09 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I1Q-MC-JDDJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01604408
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14499
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    12 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study, in older patients who have fallen recently and have muscle weakness, is to test the hypothesis that LY2495655 will increase appendicular lean body mass( aLBM) versus placebo 24 weeks after starting treatment.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 18
    Country: Number of subjects enrolled
    France: 25
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    United States: 73
    Country: Number of subjects enrolled
    Argentina: 36
    Country: Number of subjects enrolled
    Australia: 36
    Worldwide total number of subjects
    201
    EEA total number of subjects
    56
    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)
    0
    From 65 to 84 years
    144
    85 years and over
    57

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No text entered.

    Period 1
    Period 1 title
    Treatment 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
    		 Experimental: LY2495655
    Arm description
    		 Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2495655
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.

    Number of subjects in period 1
    		Experimental: LY2495655 Placebo
    Started
    102
    99
    Received at Least 1 Dose of Study Drug
    102
    99
    Completed
    86
    87
    Not completed
    16
    12
         Consent withdrawn by subject
    6
    3
         Adverse event, non-fatal
    6
    5
         Protocol violation
    2
    2
         Death
    1
    -
         Sponsor decision
    1
    1
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Observation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental: LY2495655
    Arm description
    		 Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2495655
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.

    Number of subjects in period 2
    		Experimental: LY2495655 Placebo
    Started
    86
    87
    Completed
    85
    84
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental: LY2495655
    Reporting group description
    		 Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.

    Reporting group values
    		 Experimental: LY2495655 Placebo Total
    Number of subjects
    		 102 99 201
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 81.84 ( 4.73 ) 82.57 ( 5.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 75 65 140
        Male
    		 27 34 61
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 17 19 36
        Not Hispanic or Latino
    		 48 45 93
        Unknown or Not Reported
    		 37 35 72
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 101 98 199
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        France
    		 13 12 25
        United States
    		 37 36 73
        Argentina
    		 17 19 36
        Australia
    		 19 17 36
        Germany
    		 6 7 13
        Sweden
    		 10 8 18

    End points

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    End points reporting groups
    Reporting group title
    Experimental: LY2495655
    Reporting group description
    		 Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
    Reporting group title
    Experimental: LY2495655
    Reporting group description
    		 Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.

    Primary: Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)

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    End point title
    		 Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
    End point description
    Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
    End point type
    Primary
    End point timeframe
    Baseline to 24 weeks
    End point values
    		 Experimental: LY2495655 Placebo
    Number of subjects analysed
    77 [1]
    82 [2]
    Units: Kilograms
        least squares mean (standard error)
    0.303 ( 0.085 )
    -0.123 ( 0.083 )
    Notes
    [1] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.
    [2] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.
    Statistical analysis title
    		 Change From Baseline to 24 Week Endpoint in aLBM
    Comparison groups
    Experimental: LY2495655 v Placebo
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.426
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.192
         upper limit
    		 0.66

    Secondary: Change From Baseline in Stair Climbing (StC) Time

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    End point title
    		 Change From Baseline in Stair Climbing (StC) Time
    End point description
    Change from baseline to the 24-week endpoint in StC time is presented. StC time was assessed by measuring the fastest time achieved to climb 4 steps on a 4-step staircase (the test was performed 2 times). LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline StC score as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline to 24 weeks
    End point values
    		 Experimental: LY2495655 Placebo
    Number of subjects analysed
    80 [3]
    84 [4]
    Units: Seconds
        least squares mean (standard deviation)
    -0.276 ( 0.182 )
    0.184 ( 0.178 )
    Notes
    [3] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.
    [4] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Repeated Chair Stands (RCS) Time

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    End point title
    		 Change From Baseline in Repeated Chair Stands (RCS) Time
    End point description
    Change from baseline to 24-week endpoint in RCS time is presented. In the RCS test, participants were asked to rise from a chair 5 times as fast as possible with their arms folded on their chest. Performance was measured in seconds, as the time from the initial seated position to the final standing position. LS means were calculated using an MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline RCS time as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline to 24 weeks
    End point values
    		 Experimental: LY2495655 Placebo
    Number of subjects analysed
    53 [5]
    64 [6]
    Units: Seconds
        least squares mean (standard error)
    -1.888 ( 0.588 )
    0.826 ( 0.551 )
    Notes
    [5] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.
    [6] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Usual Gait Speed (uGS) at 4 Meters

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    End point title
    		 Change From Baseline in Usual Gait Speed (uGS) at 4 Meters
    End point description
    Change from baseline to the 24-week endpoint in uGS is presented. Two attempts to walk a 4-meter distance were made. LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline uGS as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline to 24 weeks
    End point values
    		 Experimental: LY2495655 Placebo
    Number of subjects analysed
    80 [7]
    85 [8]
    Units: meters per second (m/s)
        least squares mean (standard error)
    0.03 ( 0.017 )
    0.013 ( 0.017 )
    Notes
    [7] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.
    [8] - All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I1Q-MC-JDDJ
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    LY2495655
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 LY2495655 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 102 (26.47%)
    18 / 99 (18.18%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma pancreas
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-hodgkin's lymphoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic carcinoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    hypertensive crisis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    rotator cuff repair
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    device dislocation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    injection site haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoxia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary arterial hypertension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory alkalosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    international normalised ratio increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    liver function test abnormal
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    avulsion fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fibula fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    scapula fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thoracic vertebral fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block first degree
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinoatrial block
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    syncope
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thalamus haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    normochromic normocytic anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    deafness unilateral
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis ischaemic
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tooth socket haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    urinary retention
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    groin pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain in jaw
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    diverticulitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epiglottitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia urinary tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    herpes zoster oticus
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lactic acidosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY2495655 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 102 (88.24%)
    77 / 99 (77.78%)
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    9 / 99 (9.09%)
         occurrences all number
    9
    11
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    4 / 99 (4.04%)
         occurrences all number
    8
    4
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 102 (3.92%)
    5 / 99 (5.05%)
         occurrences all number
    4
    5
    fatigue
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    12 / 102 (11.76%)
    3 / 99 (3.03%)
         occurrences all number
    14
    3
    injection site bruising
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    6 / 102 (5.88%)
    0 / 99 (0.00%)
         occurrences all number
    8
    0
    injection site pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    20 / 102 (19.61%)
    5 / 99 (5.05%)
         occurrences all number
    69
    7
    pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    5 / 102 (4.90%)
    6 / 99 (6.06%)
         occurrences all number
    5
    8
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    3 / 99 (3.03%)
         occurrences all number
    8
    3
    diarrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    6 / 102 (5.88%)
    7 / 99 (7.07%)
         occurrences all number
    8
    8
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    4 / 99 (4.04%)
         occurrences all number
    7
    5
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    19 / 102 (18.63%)
    13 / 99 (13.13%)
         occurrences all number
    20
    13
    back pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    11 / 102 (10.78%)
    4 / 99 (4.04%)
         occurrences all number
    11
    4
    muscle spasms
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    3 / 99 (3.03%)
         occurrences all number
    9
    3
    pain in extremity
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    10 / 99 (10.10%)
         occurrences all number
    9
    10
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 102 (6.86%)
    8 / 99 (8.08%)
         occurrences all number
    10
    8
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 102 (2.94%)
    6 / 99 (6.06%)
         occurrences all number
    3
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2012
    Creation of an assessment committee independent from the study team (for safety monitoring.
    08 Jun 2012
    Planned additional interim analysis after 70 patients have been enrolled.
    04 Sep 2012
    Addition of some screening blood tests and related exclusion criteria (hypothyroidism, male hypogonadism, hyponatremia, polymyalgia rheumatica.

    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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