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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 Undergoing Elective Total Hip Arthroplasty (eTHA)

    Summary
    EudraCT number
    		 2011-000426-29
    Trial protocol
    		 FI   DK   EE   ES   SE   AT   BE   FR  
    Global end of trial date
    19 Feb 2014

    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-JDDE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01369511
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11671
    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
    19 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older patients undergoing elective total hip arthroplasty (eTHA).
    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
    		 The first injection of study drug was performed 10+/- 6 days before elective total hip replacement.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2011
    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
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    Austria: 17
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    Estonia: 41
    Country: Number of subjects enrolled
    Finland: 22
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    United States: 113
    Country: Number of subjects enrolled
    Canada: 74
    Country: Number of subjects enrolled
    Japan: 45
    Worldwide total number of subjects
    400
    EEA total number of subjects
    168
    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)
    131
    From 65 to 84 years
    262
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No text entered

    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
    		 Placebo
    Arm description
    		 Placebo: Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo Comparator administered subcutaneously (SC) every 4 weeks (Q4W) for 12 weeks.

    Arm title
    		 35 mg LY2495655
    Arm description
    		 LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
    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
    LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Arm title
    		 105 mg LY2495655
    Arm description
    		 LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
    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
    LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Arm title
    		 315 mg LY2495655
    Arm description
    		 LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
    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
    LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Number of subjects in period 1
    		Placebo 35 mg LY2495655 105 mg LY2495655 315 mg LY2495655
    Started
    98
    104
    98
    100
    Received at Least 1 Dose of Study Drug
    98
    103
    98
    100
    Completed
    85
    91
    87
    89
    Not completed
    13
    13
    11
    11
         Physician decision
    3
    4
    -
    -
         Consent withdrawn by subject
    5
    6
    4
    6
         Adverse event, non-fatal
    1
    1
    5
    -
         Protocol violation
    -
    1
    -
    2
         Sponsor decision
    2
    -
    1
    -
         Lost to follow-up
    -
    1
    1
    2
         Entry criteria not met
    2
    -
    -
    1

    Baseline characteristics

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

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 400 400
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 131 131
        From 65-84 years
    		 262 262
        85 years and over
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 234 234
        Male
    		 166 166
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 214 214
        Unknown or Not Reported
    		 184 184
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 46 46
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 5 5
        White
    		 349 349
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Region of Enrollment
    Units: Subjects
        France
    		 4 4
        United States
    		 113 113
        Estonia
    		 41 41
        Canada
    		 74 74
        Finland
    		 22 22
        Belgium
    		 20 20
        Spain
    		 26 26
        Austria
    		 17 17
        Denmark
    		 34 34
        Japan
    		 45 45
        Sweden
    		 4 4
    Body Mass Index (BMI)
    Measure Description: BMI was calculated by weight in kilograms divided by height in meters squared.
    Units: kilograms per meter squared (kg/m^2)
        arithmetic mean (standard deviation)
    		 28.61 ( 4.63 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Reporting group title
    35 mg LY2495655
    Reporting group description
    		 LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Reporting group title
    105 mg LY2495655
    Reporting group description
    		 LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Reporting group title
    315 mg LY2495655
    Reporting group description
    		 LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)

    Primary: Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12

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    End point title
    		 Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
    End point description
    The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis. Analysis Population Description: Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.
    End point type
    Primary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 Placebo 35 mg LY2495655 105 mg LY2495655 315 mg LY2495655
    Number of subjects analysed
    70
    68
    76
    69
    Units: Percentage of change in aLBM
        least squares mean (standard error)
    0.297 ( 0.492 )
    0.741 ( 0.5 )
    1.018 ( 0.471 )
    1.357 ( 0.494 )
    Statistical analysis title
    		 Placebo, 35 mg LY2495655
    Comparison groups
    Placebo v 35 mg LY2495655
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.527 [2]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - At Week 12
    [2] - P-values are from type 3 tests.
    Statistical analysis title
    		 Placebo, 105 mg LY2495655
    Statistical analysis description
    At Week 12
    Comparison groups
    Placebo v 105 mg LY2495655
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291 [3]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [3] - P-values are from type 3 tests.
    Statistical analysis title
    		 Placebo, 315 mg LY2495655
    Comparison groups
    Placebo v 315 mg LY2495655
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.129 [4]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [4] - P-values are from type 3 tests.

    Secondary: Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16

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    End point title
    		 Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
    End point description
    The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis. Analysis Population Description: Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.
    End point type
    Secondary
    End point timeframe
    Baseline, 4 Weeks, 8 Weeks, and 16 Weeks
    End point values
    		 Placebo 35 mg LY2495655 105 mg LY2495655 315 mg LY2495655
    Number of subjects analysed
    74 [5]
    69 [6]
    80 [7]
    72 [8]
    Units: Percentage of change in aLBM (3 Limbs)
    least squares mean (standard error)
        Week 4
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Week 8 (n=74, 69, 80, 72)
    -0.9 ( 0.485 )
    -0.68 ( 0.498 )
    0.34 ( 0.466 )
    0.585 ( 0.488 )
        Week 16 (n=69, 67, 79, 69)
    -0.102 ( 0.494 )
    0.606 ( 0.502 )
    2.058 ( 0.467 )
    1.784 ( 0.494 )
    Notes
    [5] - Wk 4 data not collected per protocol, swelling associated with surgery would confound results.
    [6] - Wk 4 data not collected per protocol, swelling associated with surgery would confound results.
    [7] - Wk 4 data not collected per protocol, swelling associated with surgery would confound results.
    [8] - Wk 4 data not collected per protocol, swelling associated with surgery would confound results.
    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-JDDE
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    35 mg LY2495655
    Reporting group description
    		 -

    Reporting group title
    105 mg LY2495655
    Reporting group description
    		 -

    Reporting group title
    315 mg LY2495655
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 35 mg LY2495655 105 mg LY2495655 315 mg LY2495655
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 98 (14.29%)
    8 / 104 (7.69%)
    16 / 98 (16.33%)
    3 / 100 (3.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lymphoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-small cell lung cancer
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed [1]
    0 / 39 (0.00%)
    0 / 34 (0.00%)
    1 / 47 (2.13%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    venous thrombosis limb
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    device dislocation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pneumonia aspiration
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    alcohol abuse
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    delirium
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood creatinine increased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    confusion postoperative
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    periprosthetic fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural haematoma
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wrist fracture
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    myocardial infarction
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sick sinus syndrome
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tachycardia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    encephalopathy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metabolic encephalopathy
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhagic anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    petechiae
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal failure
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint ankylosis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 104 (0.96%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    1 / 98 (1.02%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 104 (0.00%)
    2 / 98 (2.04%)
    2 / 100 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hyperkalaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 104 (0.00%)
    0 / 98 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 35 mg LY2495655 105 mg LY2495655 315 mg LY2495655
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 98 (73.47%)
    76 / 104 (73.08%)
    66 / 98 (67.35%)
    68 / 100 (68.00%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    6 / 98 (6.12%)
    3 / 104 (2.88%)
    3 / 98 (3.06%)
    1 / 100 (1.00%)
         occurrences all number
    6
    3
    3
    1
    hypotension
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    9 / 98 (9.18%)
    9 / 104 (8.65%)
    10 / 98 (10.20%)
    12 / 100 (12.00%)
         occurrences all number
    11
    10
    10
    12
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 98 (7.14%)
    4 / 104 (3.85%)
    4 / 98 (4.08%)
    9 / 100 (9.00%)
         occurrences all number
    9
    4
    4
    9
    injection site erythema
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 104 (0.96%)
    2 / 98 (2.04%)
    6 / 100 (6.00%)
         occurrences all number
    0
    1
    3
    11
    injection site pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    6 / 104 (5.77%)
    13 / 98 (13.27%)
    12 / 100 (12.00%)
         occurrences all number
    3
    9
    30
    30
    local swelling
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    5 / 98 (5.10%)
    6 / 104 (5.77%)
    7 / 98 (7.14%)
    3 / 100 (3.00%)
         occurrences all number
    5
    6
    7
    3
    pyrexia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    11 / 98 (11.22%)
    18 / 104 (17.31%)
    13 / 98 (13.27%)
    14 / 100 (14.00%)
         occurrences all number
    15
    22
    24
    14
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    7 / 104 (6.73%)
    7 / 98 (7.14%)
    5 / 100 (5.00%)
         occurrences all number
    3
    7
    8
    5
    Investigations
    oxygen saturation decreased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 98 (7.14%)
    3 / 104 (2.88%)
    3 / 98 (3.06%)
    6 / 100 (6.00%)
         occurrences all number
    7
    3
    3
    6
    Injury, poisoning and procedural complications
    anaemia postoperative
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 98 (2.04%)
    3 / 104 (2.88%)
    2 / 98 (2.04%)
    6 / 100 (6.00%)
         occurrences all number
    2
    4
    2
    6
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    13 / 98 (13.27%)
    9 / 104 (8.65%)
    6 / 98 (6.12%)
    9 / 100 (9.00%)
         occurrences all number
    16
    13
    7
    11
    headache
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    0 / 98 (0.00%)
    6 / 104 (5.77%)
    3 / 98 (3.06%)
    2 / 100 (2.00%)
         occurrences all number
    0
    6
    4
    2
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    4 / 98 (4.08%)
    8 / 104 (7.69%)
    7 / 98 (7.14%)
    11 / 100 (11.00%)
         occurrences all number
    4
    8
    7
    11
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    8 / 98 (8.16%)
    14 / 104 (13.46%)
    7 / 98 (7.14%)
    9 / 100 (9.00%)
         occurrences all number
    9
    15
    7
    9
    diarrhoea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    2 / 98 (2.04%)
    8 / 104 (7.69%)
    4 / 98 (4.08%)
    5 / 100 (5.00%)
         occurrences all number
    2
    8
    4
    5
    nausea
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    12 / 98 (12.24%)
    20 / 104 (19.23%)
    16 / 98 (16.33%)
    21 / 100 (21.00%)
         occurrences all number
    12
    23
    18
    21
    vomiting
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    9 / 98 (9.18%)
    16 / 104 (15.38%)
    9 / 98 (9.18%)
    12 / 100 (12.00%)
         occurrences all number
    10
    20
    11
    12
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    7 / 98 (7.14%)
    3 / 104 (2.88%)
    2 / 98 (2.04%)
    3 / 100 (3.00%)
         occurrences all number
    8
    3
    2
    3
    Renal and urinary disorders
    urinary retention
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    8 / 98 (8.16%)
    5 / 104 (4.81%)
    9 / 98 (9.18%)
    8 / 100 (8.00%)
         occurrences all number
    8
    5
    9
    8
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    11 / 98 (11.22%)
    22 / 104 (21.15%)
    11 / 98 (11.22%)
    14 / 100 (14.00%)
         occurrences all number
    15
    30
    12
    23
    back pain
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    9 / 104 (8.65%)
    12 / 98 (12.24%)
    2 / 100 (2.00%)
         occurrences all number
    4
    9
    14
    2
    myalgia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    9 / 104 (8.65%)
    3 / 98 (3.06%)
    4 / 100 (4.00%)
         occurrences all number
    3
    10
    4
    5
    pain in extremity
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    11 / 104 (10.58%)
    5 / 98 (5.10%)
    4 / 100 (4.00%)
         occurrences all number
    3
    13
    6
    7
    Infections and infestations
    influenza
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    6 / 98 (6.12%)
    1 / 104 (0.96%)
    2 / 98 (2.04%)
    2 / 100 (2.00%)
         occurrences all number
    6
    1
    2
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 104 (2.88%)
    2 / 98 (2.04%)
    6 / 100 (6.00%)
         occurrences all number
    1
    4
    2
    7
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 104 (1.92%)
    1 / 98 (1.02%)
    9 / 100 (9.00%)
         occurrences all number
    3
    2
    1
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Mar 2011
    Addition of fecal occult blood test at screening
    05 Jul 2011
    Patient monitoring time was increased from 15 to 30 minutes after study drug injection
    23 Sep 2011
    Added 44 patients in Japan, and ensure the third interim analysis did not need to wait for the Japanese patients to have completed. Moved leg strength test from secondary to exploratory objective
    09 Apr 2012
    In order to speed up enrollment, changed inclusion criterion [1], from patients 60 years or older to males or females of non child-bearing potential, aged 50 years or older. Also, the window between Visit 2 and surgery was shortened from 14 ± 6 days before the eTHA surgery to 10 ± 6 days. Also, allowed study sites to obtain 25-hydroxyvitamin D levels for eligibility purposes from the local laboratory
    17 Oct 2012
    Modification of Inclusion Criterion to further define effective methods of contraception, and addition of Exclusion Criterion for patients who have experienced a severe allergic reaction from a monoclonal antibody.
    03 May 2013
    Added the following inclusion criteria due to insufficient quality of some scans during first part of the study: Have a baseline DEXA scan (at or before Visit 2) that captures all 4 limbs entirely in the DEXA scan field in the opinion of the investigator site’s DEXA technician

    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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