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A Study of LY2541546 in Healthy Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01742078
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: LY2541546 - IV
Drug: LY2541546 - SC
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL Placebo
Hide Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL Single dose of placebo administered IV or SC
Period Title: Overall Study
Started 6 6 6 6 6 6 6 6 12
RECEIVED STUDY DRUG 6 6 6 6 6 6 6 6 12
Completed 6 6 6 5 6 6 6 6 12
Not Completed 0 0 0 1 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             0             0             0             0
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL Placebo Total
Hide Arm/Group Description Participants received 7.5 mg LY2541546 IV Participants received25 mg LY2541546 IV Participants received 75 mg LY2541546 IV Participants received225 mg LY541546 IV Participants received750 mg LY2541546 IV Participants received 150 mg LY2541546 subcutaneously (SC) Participants received 225 mg LY2541546 IV. Open label(OL) Participants received 750 mg LY2541546 IV, OL Participants single dose of placebo administered IV or SC Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 6 12 60
Hide Baseline Analysis Population Description
All participants who received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 60 participants
54.0  (3.7) 56.3  (4.6) 60.0  (5.3) 53.6  (4.6) 59.0  (5.7) 58.5  (4.5) 59.7  (6.7) 64.2  (5.9) 57.1  (5.2) 57.9  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 60 participants
Female 6 6 6 6 6 6 6 6 12 60
Male 0 0 0 0 0 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 60 participants
Caucasian 5 5 6 5 5 6 6 6 11 55
African 1 1 0 0 1 0 0 0 0 3
Native American 0 0 0 1 0 0 0 0 0 1
West Asian 0 0 0 0 0 0 0 0 1 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 60 participants
6 6 6 6 6 6 6 6 12 60
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
Hide 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
  • or is considered significant by the investigator for any other reason.
Time Frame Day 1 through Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug.
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description:
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Single dose of 25 mg LY2541546 administered IV
Single dose of 75 mg LY2541546 administered IV
Single dose of 225 mg LY2541546 administered IV
Single dose of 750 mg LY2541546 administered IV
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Single dose of placebo administered IV or SC
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Single dose of 750 mg LY2541546 administered IV, OL
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 6 6
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0
2.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
Hide Description [Not Specified]
Time Frame Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable results for PK analysis.
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description:
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Single dose of 25 mg LY2541546 administered IV
Single dose of 75 mg LY2541546 administered IV
Single dose of 225 mg LY2541546 administered IV
Single dose of 750 mg LY2541546 administered IV
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Single dose of 750 mg LY2541546 administered IV, OL
Overall Number of Participants Analyzed 6 6 5 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picomol*hr/mL
411
(51%)
2540
(22%)
16400
(16%)
86600
(14%)
390000
(14%)
9150
(40%)
94500
(10%)
507000
(14%)
3.Secondary Outcome
Title Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
Hide 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) and is calculate by dexascan.
Time Frame Baseline (predose), Day 29 anytime, Day 85 anytime
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had evaluable results at the analyzed time points.
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description:
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Single dose of 25 mg LY2541546 administered IV
Single dose of 75 mg LY2541546 administered IV
Single dose of 225 mg LY2541546 administered IV
Single dose of 750 mg LY2541546 administered IV
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Single dose of placebo administered IV or SC
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Single dose of 750 mg LY2541546 administered IV, OL
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 6 6
Least Squares Mean (90% Confidence Interval)
Unit of Measure: gram per square centimeter (g/cm^2)
Day 29 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 11 participants 6 participants 6 participants
0.01
(-0.01 to 0.02)
-0.01
(-0.03 to 0.01)
0.01
(-0.00 to 0.02)
0.01
(-0.00 to 0.03)
0.00
(-0.01 to 0.02)
0.00
(-0.01 to 0.01)
-0.00
(-0.01 to 0.01)
0.01
(-0.00 to 0.03)
-0.00
(-0.02 to 0.01)
Day 85 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 6 participants 6 participants
-0.00
(-0.02 to 0.01)
-0.01
(-0.02 to 0.01)
0.01
(-0.00 to 0.03)
0.02
(0.00 to 0.03)
0.03
(0.02 to 0.05)
0.01
(-0.00 to 0.02)
-0.00
(-0.02 to 0.01)
0.01
(-0.01 to 0.02)
0.02
(0.00 to 0.03)
4.Secondary Outcome
Title Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Hide 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. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.
Time Frame Baseline (predose), Day 29 anytime, Day 85 anytime
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had evaluable results at the analyzed timepoints.
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description:
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Single dose of 25 mg LY2541546 administered IV
Single dose of 75 mg LY2541546 administered IV
Single dose of 225 mg LY2541546 administered IV
Single dose of 750 mg LY2541546 administered IV
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Single dose of placebo administered IV or SC
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Single dose of 750 mg LY2541546 administered IV, OL
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 6 6
Least Squares Mean (90% Confidence Interval)
Unit of Measure: percentage of change from baseline
Day 29 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 11 participants 6 participants 6 participants
9.36
(-38.79 to 57.52)
44.00
(-4.15 to 92.16)
24.86
(-23.30 to 73.01)
47.54
(-2.50 to 97.59)
224.16
(176.00 to 272.32)
31.42
(-16.74 to 79.57)
6.18
(-28.37 to 40.73)
106.76
(58.60 to 154.91)
334.52
(286.36 to 382.68)
Day 85 Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 6 participants 6 participants
9.28
(-22.36 to 40.93)
25.77
(-5.88 to 57.42)
14.27
(-17.38 to 45.92)
24.07
(-7.58 to 55.72)
33.84
(2.20 to 65.49)
19.24
(-12.41 to 50.89)
9.86
(-12.52 to 32.24)
33.59
(1.95 to 65.24)
23.98
(-7.67 to 55.62)
5.Secondary Outcome
Title Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Hide Description A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
Time Frame Day 1: Predose, Day 29 anytime, Day 85 anytime
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had evaluable results at the analyzed time points.
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description:
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
Single dose of 25 mg LY2541546 administered IV
Single dose of 75 mg LY2541546 administered IV
Single dose of 225 mg LY2541546 administered IV
Single dose of 750 mg LY2541546 administered IV
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
Single dose of placebo administered IV or SC
Single dose of 225 mg LY2541546 administered IV, open label (OL)
Single dose of 750 mg LY2541546 administered IV, OL
Overall Number of Participants Analyzed 6 6 6 6 6 6 12 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 0 0 0 0 0 0 0 0 0
Day 29 0 0 0 2 0 0 0 0 0
Day 85 0 0 1 4 1 2 0 0 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Hide Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
All-Cause Mortality
7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   5/6 (83.33%)      6/6 (100.00%)      4/6 (66.67%)      4/6 (66.67%)      4/6 (66.67%)      5/6 (83.33%)      7/12 (58.33%)      6/6 (100.00%)      5/6 (83.33%)    
Cardiac disorders                   
Conduction disorder  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Ventricular tachycardia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Ear and labyrinth disorders                   
Ear pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vertigo  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Eye disorders                   
Conjunctivitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Conjunctivitis allergic  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Eye pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Lacrimation increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Visual disturbance  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Gastrointestinal disorders                   
Abdominal pain  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Aphthous stomatitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dental caries  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Diarrhoea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dyspepsia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Flatulence  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nausea  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Stomach discomfort  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Toothache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Vomiting  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  3 0/6 (0.00%)  0
General disorders                   
Application site irritation  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Catheter site erythema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Catheter site pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Fatigue  1  3/6 (50.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nodule  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Pyrexia  1  0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vessel puncture site haematoma  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations                   
Gastroenteritis viral  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Herpes simplex  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Myringitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Otitis media  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Upper respiratory tract infection  1  1/6 (16.67%)  1 3/6 (50.00%)  5 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Viral infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Viral upper respiratory tract infection  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 3/6 (50.00%)  4 1/6 (16.67%)  1 1/6 (16.67%)  1 1/12 (8.33%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2
Injury, poisoning and procedural complications                   
Arthropod bite  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Contusion  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Fall  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Joint sprain  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Thermal burn  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                   
Anorexia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Back pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 2/12 (16.67%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
Joint swelling  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Muscle spasms  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Myalgia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Neck pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                   
Dizziness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/12 (8.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Headache  1  2/6 (33.33%)  3 3/6 (50.00%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/12 (8.33%)  1 3/6 (50.00%)  3 1/6 (16.67%)  1
Hypoaesthesia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Syncope vasovagal  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders                   
Insomnia  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Stress  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders                   
Polyuria  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Urinary incontinence  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Nasal congestion  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Pharyngolaryngeal pain  1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Productive cough  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory tract congestion  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Sinus congestion  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Acne  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Alopecia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Dermatitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Dermatitis contact  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 1/6 (16.67%)  1 1/6 (16.67%)  1
Vascular disorders                   
Hot flush  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hypertension  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01742078     History of Changes
Other Study ID Numbers: 11952
I2M-MC-GSDA ( Other Identifier: Eli Lilly and Company )
First Submitted: December 3, 2012
First Posted: December 5, 2012
Results First Submitted: November 22, 2013
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019