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A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01742091
Collaborator
(none)
59
Enrollment
5
Locations
6
Arms
5.9
Duration (Months)
11.8
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein). The study will also test how long it takes the study drug to get into the body, how long it takes the body to get rid of it, the overall effect of the study drug on the body, and whether antibodies to the study drug are formed.

Condition or Disease Intervention/Treatment Phase
  • Drug: LY2541546 - SC
  • Drug: LY2541546 - IV
  • Drug: Placebo - SC
  • Drug: Placebo - IV
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple Dose Study of LY2541546 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Postmenopausal Women
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 180 mg LY2541546 SC Q4W

180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.

Drug: LY2541546 - SC
Administered SC
Other Names:
  • Blosozumab

    • Drug: Placebo - SC
    Administered SC
    Experimental: 270 mg LY2541546 SC Q2W

    270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.

    Drug: LY2541546 - SC
    Administered SC
    Other Names:
  • Blosozumab

    		•
    Experimental: 270 mg LY2541546 SC Q4W

    270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.

    Drug: LY2541546 - SC
    Administered SC
    Other Names:
  • Blosozumab

    • Drug: Placebo - SC
    Administered SC
    Experimental: 540 mg LY2541546 IV Q4W

    540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    • Drug: Placebo - IV
    Administered IV
    Experimental: 750 mg LY2541546 IV Q2W

    750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Placebo Comparator: Placebo Q2W

    Placebo administered IV or SC once every 2 weeks for 8 weeks.

    Drug: Placebo - SC
    Administered SC

    Drug: Placebo - IV
    Administered IV

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Day 1 through Day 141]

      An SAE is any AE from this study that results in one of the following outcomes: death initial or prolonged inpatient hospitalization a life-threatening experience (that is, immediate risk of dying) persistent or significant disability/incapacity congenital anomaly/birth defect is considered significant by the investigator for any other reason

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546 [Day 1 through Day 141]

      Weekly AUC (AUC[0-tau]) during the first and last dosing interval for each participant receiving LY2541546 is reported.

    2. Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85 [Predose and Day 85]

      A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.

    3. Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies [Predose (Day 1) and Postdose (Day 29, 85 and 141)]

    4. Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) [Predose, through Day 141]

      N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy postmenopausal females, as determined by medical history and physical examination

    • Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

    • Acceptable clinical laboratory test results, blood pressure and heart rate

    • Have given written informed consent

    Exclusion Criteria:

    • Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication

    • Have received study treatment in any trial of an investigational osteoporosis treatment, including LY2561553 (parathyroid hormone receptor modulator), within 12 weeks of screening or 5 half-lives, whichever is longer

    • Known allergies to LY2541546, its constituents, or related compounds

    • Persons who have previously participated in this study or any other study of LY2541546

    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

    • History or presence of low platelet count, bleeding issues or family history of bleeding disorders

    • Paget's disease, parathyroid disease, or thyroid disease

    • Fracture of a long bone within 12 weeks of screening

    • Regular use of known drugs of abuse and/or positive findings on urinary drug screening

    • Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen

    • Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months

    • Blood donation within the last month

    • Are unwilling or unable to maintain their normal pattern of alcohol, caffeine, smoking, and exercise from the start to the end of the study or to abide by the clinical research unit restrictions. Note: Average weekly alcohol intake must not exceed 14 units per week

    • Are unable or unwilling to refrain from nicotine usage during Clinical Research Unit (CRU) confinement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Daytona Beach Florida United States 32117
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Honolulu Hawaii United States 96813
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Evansville Indiana United States 47710
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Austin Texas United States 78752
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01742091
    Other Study ID Numbers:
    • 13405
    • I2M-MC-GSDE
    First Posted:
    Dec 5, 2012
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Sep 1, 2017
    Keywords provided by Eli Lilly and Company
    Postmenopausal females
    Volunteers

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    Period Title: Overall Study
    STARTED 9 11 10 9 8 12
    RECEIVED STUDY DRUG 9 11 10 9 8 12
    COMPLETED 9 11 10 8 7 10
    NOT COMPLETED 0 0 0 1 1 2

    Baseline Characteristics

    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W Total
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks. Total of all reporting groups
    Overall Participants 9 11 10 9 8 12 59
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58
    (5.1)
    57
    (5.5)
    56
    (7.5)
    57
    (8.3)
    66
    (8.8)
    62
    (10.5)
    59
    (8.3)
    Sex: Female, Male (Count of Participants)
    Female
    9
    100%
    11
    100%
    10
    100%
    9
    100%
    8
    100%
    12
    100%
    59
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    Asian
    0
    0%
    4
    36.4%
    0
    0%
    0
    0%
    4
    50%
    4
    33.3%
    12
    20.3%
    Black or African American
    0
    0%
    0
    0%
    1
    10%
    1
    11.1%
    0
    0%
    0
    0%
    2
    3.4%
    White
    9
    100%
    7
    63.6%
    9
    90%
    8
    88.9%
    4
    50%
    8
    66.7%
    45
    76.3%
    Region of Enrollment (participants) [Number]
    United States
    9
    100%
    11
    100%
    10
    100%
    9
    100%
    8
    100%
    12
    100%
    59
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
    Description An SAE is any AE from this study that results in one of the following outcomes: death initial or prolonged inpatient hospitalization a life-threatening experience (that is, immediate risk of dying) persistent or significant disability/incapacity congenital anomaly/birth defect is considered significant by the investigator for any other reason
    Time Frame Day 1 through Day 141

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug.
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    Measure Participants 9 11 10 9 8 12
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546
    Description Weekly AUC (AUC[0-tau]) during the first and last dosing interval for each participant receiving LY2541546 is reported.
    Time Frame Day 1 through Day 141

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had sufficient evaluable results for PK analysis.
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
    Measure Participants 8 11 10 8 7
    First Dose
    6.77
    (2.00)
    18.5
    (5.27)
    13.9
    (4.73)
    61.2
    (7.23)
    167
    (11.9)
    Last Dose
    6.85
    (2.09)
    38.4
    (13.3)
    14.7
    (5.45)
    68.9
    (11.4)
    332
    (54.6)
    3. Secondary Outcome
    Title Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
    Description A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.
    Time Frame Predose and Day 85

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable BMD results at the analyzed time points.
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    Measure Participants 9 11 10 8 7 11
    Least Squares Mean (90% Confidence Interval) [gram per square centimeter (g/cm^2)]
    0.02
    0.05
    0.03
    0.05
    0.06
    0.00
    4. Secondary Outcome
    Title Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
    Description
    Time Frame Predose (Day 1) and Postdose (Day 29, 85 and 141)

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable antibody results at the analyzed time points.
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    Measure Participants 9 11 10 9 8 12
    Day 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    12.5%
    0
    0%
    Day 29
    1
    11.1%
    0
    0%
    1
    10%
    0
    0%
    0
    0%
    0
    0%
    Day 85
    3
    33.3%
    2
    18.2%
    4
    40%
    0
    0%
    0
    0%
    0
    0%
    Day 141
    3
    33.3%
    2
    18.2%
    2
    20%
    1
    11.1%
    5
    62.5%
    0
    0%
    5. Secondary Outcome
    Title Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
    Description N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.
    Time Frame Predose, through Day 141

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable P1NP results at the analyzed time points.
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    Measure Participants 9 11 10 8 7 11
    Day 29
    20.36
    121.68
    42.60
    124.47
    134.93
    1.36
    Day 85
    1.69
    24.19
    9.66
    52.44
    91.06
    4.20

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Arm/Group Description 180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks. 270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind. 540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind. 750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks. Placebo administered IV or SC once every 2 weeks for 8 weeks.
    All Cause Mortality
    180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/11 (0%) 0/10 (0%) 0/9 (0%) 1/8 (12.5%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Concussion 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Other (Not Including Serious) Adverse Events
    180 mg LY2541546 SC Q4W 270 mg LY2541546 SC Q2W 270 mg LY2541546 SC Q4W 540 mg LY2541546 IV Q4W 750 mg LY2541546 IV Q2W Placebo Q2W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/9 (77.8%) 11/11 (100%) 7/10 (70%) 5/9 (55.6%) 7/8 (87.5%) 9/12 (75%)
    Cardiac disorders
    Palpitations 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Ear and labyrinth disorders
    Ear Congestion 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Ear Pain 1/9 (11.1%) 1 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Eye disorders
    Lacrimation Increased 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 2
    Gastrointestinal disorders
    Abdominal Distension 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Abdominal Pain 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 2 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Abdominal Pain Lower 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Diarrhoea 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 2/12 (16.7%) 2
    Dry Mouth 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 3 0/12 (0%) 0
    Dyspepsia 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Gingival Bleeding 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Nausea 0/9 (0%) 0 1/11 (9.1%) 1 1/10 (10%) 1 0/9 (0%) 0 1/8 (12.5%) 1 1/12 (8.3%) 1
    Rectal Haemorrhage 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Vomiting 1/9 (11.1%) 1 0/11 (0%) 0 2/10 (20%) 3 0/9 (0%) 0 1/8 (12.5%) 2 2/12 (16.7%) 2
    General disorders
    Chest Discomfort 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Chills 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Fatigue 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 2/9 (22.2%) 2 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Discomfort 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Injection Site Erythema 0/9 (0%) 0 4/11 (36.4%) 5 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Haemorrhage 2/9 (22.2%) 2 2/11 (18.2%) 3 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Injection Site Inflammation 0/9 (0%) 0 0/11 (0%) 0 2/10 (20%) 4 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Mass 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Injection Site Pain 1/9 (11.1%) 1 4/11 (36.4%) 4 2/10 (20%) 2 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Injection Site Pruritus 0/9 (0%) 0 2/11 (18.2%) 2 1/10 (10%) 2 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Rash 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Reaction 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Injection Site Warmth 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Pain 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Sensation of Pressure 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 0/12 (0%) 0
    Vessel Puncture Site Haematoma 1/9 (11.1%) 2 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 0/12 (0%) 0
    Vessel Puncture Site Pain 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Immune system disorders
    Seasonal Allergy 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 1/9 (11.1%) 1 0/8 (0%) 0 0/12 (0%) 0
    Infections and infestations
    Gastroenteritis 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Pharyngitis 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Rhinitis 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Sinusitis 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Tooth Abscess 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Upper Respiratory Tract Infection 1/9 (11.1%) 1 0/11 (0%) 0 2/10 (20%) 2 0/9 (0%) 0 2/8 (25%) 2 3/12 (25%) 3
    Injury, poisoning and procedural complications
    Animal Bite 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Burns First Degree 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Excoriation 0/9 (0%) 0 2/11 (18.2%) 3 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Foot Fracture 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Injury 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Joint Sprain 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 1/12 (8.3%) 1
    Scratch 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Tooth Fracture 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 0/12 (0%) 0
    Investigations
    Blood Thyroid Stimulating Hormone Decreased 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/9 (11.1%) 1 0/8 (0%) 0 0/12 (0%) 0
    Metabolism and nutrition disorders
    Decreased Appetite 1/9 (11.1%) 1 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/9 (11.1%) 3 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Back Pain 2/9 (22.2%) 2 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Bone Pain 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Muscle Spasms 1/9 (11.1%) 1 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Musculoskeletal Stiffness 0/9 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Myalgia 2/9 (22.2%) 2 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Neck Pain 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Pain in Extremity 1/9 (11.1%) 1 0/11 (0%) 0 1/10 (10%) 1 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Pain in Jaw 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Tendonitis 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Nervous system disorders
    Dizziness 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Dysgeusia 0/9 (0%) 0 2/11 (18.2%) 2 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Head Discomfort 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Headache 1/9 (11.1%) 1 2/11 (18.2%) 2 4/10 (40%) 8 1/9 (11.1%) 1 1/8 (12.5%) 1 5/12 (41.7%) 7
    Lethargy 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Paraesthesia 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Somnolence 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Psychiatric disorders
    Anxiety 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 2/9 (22.2%) 2 0/8 (0%) 0 0/12 (0%) 0
    Dyspnoea 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Nasal Congestion 2/9 (22.2%) 2 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 1/8 (12.5%) 1 0/12 (0%) 0
    Oropharyngeal Pain 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Postnasal Drip 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Rhinitis Allergic 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Sneezing 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Throat Irritation 0/9 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 1/12 (8.3%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Ecchymosis 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Night Sweats 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Pruritus 1/9 (11.1%) 2 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Vascular disorders
    Flushing 0/9 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0
    Hot Flush 1/9 (11.1%) 1 0/11 (0%) 0 0/10 (0%) 0 0/9 (0%) 0 0/8 (0%) 0 0/12 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01742091
    Other Study ID Numbers:
    • 13405
    • I2M-MC-GSDE
    First Posted:
    Dec 5, 2012
    Last Update Posted:
    Jul 18, 2018
    Last Verified:
    Sep 1, 2017