Trial Outcomes & Findings for A Study of LY2495655 in Healthy Subjects (NCT NCT01341470)
NCT ID: NCT01341470
Last Updated: 2019-06-17
Results Overview
Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Baseline to study completion (up to 135 days)
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
Single IV Dose 70 mg LY2495655
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
10
|
10
|
2
|
10
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
9
|
10
|
10
|
2
|
10
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
9
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Single IV Dose 70 mg LY2495655
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Overall Study
Sponsor decision
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Study of LY2495655 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
n=2 Participants
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
n=10 Participants
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
48.0 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
65.0 years
STANDARD_DEVIATION 9.2 • n=10 Participants
|
60.4 years
STANDARD_DEVIATION 8.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian/Japanese
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Weight
|
66.48 kilograms (kg)
STANDARD_DEVIATION 8.55 • n=5 Participants
|
62.04 kilograms (kg)
STANDARD_DEVIATION 7.31 • n=7 Participants
|
63.29 kilograms (kg)
STANDARD_DEVIATION 12.56 • n=5 Participants
|
64.05 kilograms (kg)
STANDARD_DEVIATION 9.08 • n=4 Participants
|
57.15 kilograms (kg)
STANDARD_DEVIATION 12.66 • n=21 Participants
|
62.90 kilograms (kg)
STANDARD_DEVIATION 12.36 • n=10 Participants
|
63.28 kilograms (kg)
STANDARD_DEVIATION 10.05 • n=115 Participants
|
|
Height
|
167.83 centimeters (cm)
STANDARD_DEVIATION 6.81 • n=5 Participants
|
163.57 centimeters (cm)
STANDARD_DEVIATION 4.97 • n=7 Participants
|
162.01 centimeters (cm)
STANDARD_DEVIATION 8.11 • n=5 Participants
|
162.70 centimeters (cm)
STANDARD_DEVIATION 6.20 • n=4 Participants
|
165.65 centimeters (cm)
STANDARD_DEVIATION 15.06 • n=21 Participants
|
164.52 centimeters (cm)
STANDARD_DEVIATION 6.57 • n=10 Participants
|
163.89 centimeters (cm)
STANDARD_DEVIATION 6.82 • n=115 Participants
|
|
International Physical Activity Questionnaire (IPAQ)
|
1829.25 MET-minutes per week
STANDARD_DEVIATION 1619.29 • n=5 Participants
|
278.11 MET-minutes per week
STANDARD_DEVIATION 341.65 • n=7 Participants
|
130.80 MET-minutes per week
STANDARD_DEVIATION 214.24 • n=5 Participants
|
331.50 MET-minutes per week
STANDARD_DEVIATION 301.53 • n=4 Participants
|
NA MET-minutes per week
STANDARD_DEVIATION NA • n=21 Participants
|
108.40 MET-minutes per week
STANDARD_DEVIATION 198.18 • n=10 Participants
|
436.10 MET-minutes per week
STANDARD_DEVIATION 803.71 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion (up to 135 days)Population: All randomized participants
Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
n=2 Participants
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
n=10 Participants
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
|
0 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs PostdosePopulation: All participants who received study drug and had evaluable Cmax data were analyzed.
Outcome measures
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax)
Day 1
|
192 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 7
|
8.11 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 41
|
102 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 80
|
303 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
|
Pharmacokinetics, Maximum Concentration (Cmax)
Day 57
|
—
|
23.8 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 36
|
304 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 32
|
1060 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs PostdosePopulation: All participants who received study drug and had evaluable AUC data were analyzed.
Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration.
Outcome measures
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)
Day 1
|
50.5 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 11
|
2.32 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 34
|
24.0 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 59
|
79.8 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
|
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)
Day 57
|
—
|
6.82 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 39
|
88.7 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 32
|
319 nanomoles*hour per milliliter(nmol*h/mL)
Geometric Coefficient of Variation 23
|
—
|
—
|
SECONDARY outcome
Timeframe: Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs PostdosePopulation: All participants who received study drug and had evaluable Tmax data were analyzed.
Outcome measures
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)
Day 1
|
0.58 hours (h)
Interval 0.5 to 2.5
|
168 hours (h)
Interval 48.0 to 335.0
|
168 hours (h)
Interval 96.0 to 264.0
|
167 hours (h)
Interval 48.0 to 335.0
|
—
|
—
|
|
Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)
Day 57
|
—
|
48.0 hours (h)
Interval 24.0 to 168.0
|
96.0 hours (h)
Interval 47.8 to 168.0
|
96.0 hours (h)
Interval 48.0 to 168.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose armsPopulation: All randomized participants who received at least one dose of study drug.
Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)\*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment\*time interaction and a random effect of subject where baseline values were included as a covariate.
Outcome measures
| Measure |
Single IV Dose 70 mg LY2495655
n=6 Participants
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 Participants
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 Participants
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 Participants
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
n=2 Participants
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
n=10 Participants
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Percentage Change in Thigh Muscle Volume
Day 22
|
0.30 percentage change
Standard Deviation 2.33
|
0.40 percentage change
Standard Deviation 1.40
|
1.51 percentage change
Standard Deviation 2.48
|
1.80 percentage change
Standard Deviation 1.46
|
NA percentage change
Standard Deviation NA
Only 2 participants, thus not calculated
|
-1.15 percentage change
Standard Deviation 1.81
|
|
Percentage Change in Thigh Muscle Volume
Day 71
|
—
|
1.33 percentage change
Standard Deviation 2.47
|
2.88 percentage change
Standard Deviation 2.39
|
3.48 percentage change
Standard Deviation 2.84
|
—
|
-1.22 percentage change
Standard Deviation 2.97
|
Adverse Events
Single IV Dose 70 mg LY2495655
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Multiple SC Dose 17.5 mg LY2495655
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Multiple SC Dose 140 mg LY2495655
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Multiple SC Dose 420 mg LY2495655
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Single IV Dose Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Multiple SC Dose Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single IV Dose 70 mg LY2495655
n=6 participants at risk
Single 70 milligram (mg) dose LY2495655 administered intravenously (IV)
|
Multiple SC Dose 17.5 mg LY2495655
n=9 participants at risk
17.5 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
Multiple SC Dose 140 mg LY2495655
n=10 participants at risk
140 mg of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Multiple SC Dose 420 mg LY2495655
n=10 participants at risk
420 mg dose of LY2495655 administered subcutaneously (SC) every 2 weeks for 8 weeks (total 5 of doses)
|
Single IV Dose Placebo
n=2 participants at risk
Single placebo dose administered intravenously (IV)
|
Multiple SC Dose Placebo
n=10 participants at risk
Placebo dose administered subcutaneously (SC) every 2 weeks for 8 weeks (total of 5 doses)
|
|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Eye disorders
Eye irritation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Fatigue
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Influenza like illness
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site discomfort
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site erythema
|
0.00%
0/6
|
0.00%
0/9
|
30.0%
3/10 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site haematoma
|
0.00%
0/6
|
22.2%
2/9 • Number of events 2
|
60.0%
6/10 • Number of events 8
|
30.0%
3/10 • Number of events 6
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site pain
|
0.00%
0/6
|
0.00%
0/9
|
30.0%
3/10 • Number of events 5
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site pruritus
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.00%
0/6
|
0.00%
0/9
|
30.0%
3/10 • Number of events 7
|
20.0%
2/10 • Number of events 3
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Injection site urticaria
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
General disorders
Vessel puncture site haematoma
|
50.0%
3/6 • Number of events 3
|
55.6%
5/9 • Number of events 9
|
40.0%
4/10 • Number of events 4
|
30.0%
3/10 • Number of events 4
|
0.00%
0/2
|
30.0%
3/10 • Number of events 4
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
50.0%
1/2 • Number of events 2
|
0.00%
0/10
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
50.0%
1/2 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
22.2%
2/9 • Number of events 2
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6
|
22.2%
2/9 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
0.00%
0/2
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
10.0%
1/10 • Number of events 2
|
0.00%
0/2
|
0.00%
0/10
|
|
Nervous system disorders
Sleep phase rhythm disturbance
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 2
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/2
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/10
|
10.0%
1/10 • Number of events 3
|
0.00%
0/2
|
0.00%
0/10
|
|
Vascular disorders
Flushing
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
|
Vascular disorders
Haematoma
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/2
|
0.00%
0/10
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60