Trial Outcomes & Findings for A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol (NCT NCT01618916)
NCT ID: NCT01618916
Last Updated: 2019-03-15
Results Overview
TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Baseline through study completion (up to Day 127)
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
1.0 mg/kg LY3015014 Q2W
LY3015014: 1.0 milligrams per kilogram (mg/kg) given as subcutaneous (SC) injection every 2 weeks (Q2W) on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
LY3015014: 1.0 mg/kg given as SC injection every 4 weeks (Q4W) on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
Placebo Q4W
Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
11
|
9
|
5
|
4
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
12
|
10
|
11
|
9
|
5
|
4
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
7
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
1.0 mg/kg LY3015014 Q2W
LY3015014: 1.0 milligrams per kilogram (mg/kg) given as subcutaneous (SC) injection every 2 weeks (Q2W) on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
LY3015014: 1.0 mg/kg given as SC injection every 4 weeks (Q4W) on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
Placebo Q4W
Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
Baseline characteristics by cohort
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=11 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W
n=5 Participants
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
Placebo Q4W
n=4 Participants
Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 13.2 • n=21 Participants
|
47.8 years
STANDARD_DEVIATION 15.2 • n=10 Participants
|
50.6 years
STANDARD_DEVIATION 11.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
139.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 26.1 • n=5 Participants
|
119.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 48.1 • n=7 Participants
|
141.8 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 20.2 • n=5 Participants
|
151.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 30.6 • n=4 Participants
|
165.0 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 28.9 • n=21 Participants
|
122.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 36.0 • n=10 Participants
|
139.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 33.8 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to Day 127)Population: All enrolled participants who received at least 1 dose of study drug (LY3015014 or placebo).
TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
Outcome measures
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=11 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W Plus Placebo Q4W
n=9 Participants
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|
|
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
1 or More TEAEs Related to Study Drug
|
4 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours PostdosePopulation: All randomized participants who received at least 1 dose of LY3015014 and had evaluable Cmax data.
The Cmax following the first dose and last dose of LY3015014 is reported.
Outcome measures
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=10 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W Plus Placebo Q4W
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
First Dose
|
4.24 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 59
|
4.82 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 53
|
14.6 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 48
|
17.9 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 61
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
Last Dose
|
9.21 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 38
|
6.64 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 31
|
35.1 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24
|
23.1 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 51
|
—
|
SECONDARY outcome
Timeframe: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours PostdosePopulation: All randomized participants who received at least 1 dose of LY3015014 and had evaluable AUC(0-tau) data.
The AUC(0-tau) following the first dose and last dose of LY3015014 is reported.
Outcome measures
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=10 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W Plus Placebo Q4W
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])
First Dose
|
1080 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 51
|
2110 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 37
|
3890 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 47
|
8230 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 52
|
—
|
|
PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])
Last Dose
|
2450 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 35
|
2810 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 24
|
9440 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 17
|
10900 micrograms*hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 44
|
—
|
SECONDARY outcome
Timeframe: First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdosePopulation: All randomized participants who received at least 1 dose of LY3015014 and had evaluable tmax data.
The tmax following the first dose and last dose of LY3015014 is reported.
Outcome measures
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=10 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W Plus Placebo Q4W
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|
|
PK: Time of Maximum Concentration (Tmax) of LY3015014
First Dose
|
4 days
Interval 4.0 to 14.0
|
4 days
Interval 4.0 to 14.0
|
4 days
Interval 1.0 to 14.0
|
4 days
Interval 4.0 to 14.0
|
—
|
|
PK: Time of Maximum Concentration (Tmax) of LY3015014
Last Dose
|
5 days
Interval 0.0 to 5.0
|
5 days
Interval 5.0 to 6.0
|
5 days
Interval 5.0 to 5.0
|
5 days
Interval 5.0 to 14.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 43, Day 57, and Day 127Population: Randomized participants who received at least 1 dose of study drug (LY3015014 or placebo) and had a baseline and at least 1 postbaseline measurement for LDL-C.
Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction.
Outcome measures
| Measure |
1.0 mg/kg LY3015014 Q2W
n=10 Participants
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=9 Participants
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=10 Participants
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=7 Participants
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W Plus Placebo Q4W
n=9 Participants
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses and Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Days 43, 57, and 127 in LDL-C
Day 127
|
-7.52 percentage of change
Interval -14.57 to 0.47
|
-15.09 percentage of change
Interval -22.93 to -7.25
|
-23.39 percentage of change
Interval -31.89 to -14.9
|
-18.91 percentage of change
Interval -27.24 to -10.59
|
-0.99 percentage of change
Interval -13.03 to 11.05
|
|
Percent Change From Baseline to Days 43, 57, and 127 in LDL-C
Day 43
|
-49.76 percentage of change
Interval -56.71 to -42.81
|
-47.56 percentage of change
Interval -55.3 to -39.82
|
-45.20 percentage of change
Interval -53.69 to -36.7
|
-46.64 percentage of change
Interval -54.66 to -38.62
|
0.16 percentage of change
Interval -11.88 to 12.2
|
|
Percent Change From Baseline to Days 43, 57, and 127 in LDL-C
Day 57
|
-47.01 percentage of change
Interval -53.96 to -40.06
|
-44.41 percentage of change
Interval -52.25 to -36.57
|
-44.20 percentage of change
Interval -52.69 to -35.7
|
-56.80 percentage of change
Interval -64.81 to -48.78
|
-12.16 percentage of change
Interval -24.2 to -0.12
|
Adverse Events
1.0 mg/kg LY3015014 Q2W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1.0 mg/kg LY3015014 Q4W
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3.0 mg/kg LY3015014 Q2W
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
3.0 mg/kg LY3015014 Q4W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Q2W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Q4W
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.0 mg/kg LY3015014 Q2W
n=12 participants at risk
LY3015014: 1.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
1.0 mg/kg LY3015014 Q4W
n=10 participants at risk
LY3015014: 1.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
3.0 mg/kg LY3015014 Q2W
n=11 participants at risk
LY3015014: 3.0 mg/kg given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
3.0 mg/kg LY3015014 Q4W
n=9 participants at risk
LY3015014: 3.0 mg/kg given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
Placebo Q2W
n=5 participants at risk
Placebo given as SC injection Q2W on Days 1, 15, and 29 for a total of 3 doses.
|
Placebo Q4W
n=4 participants at risk
Placebo given as SC injection Q4W on Days 1 and 29 for a total of 2 doses.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 2
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Application site irritation
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Fatigue
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
36.4%
4/11 • Number of events 4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site haemorrhage
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Injection site pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site pruritus
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
27.3%
3/11 • Number of events 3
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site rash
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site reaction
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Injection site swelling
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Oedema peripheral
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
General disorders
Pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Gingival infection
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
22.2%
2/9 • Number of events 2
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
0.00%
0/10
|
9.1%
1/11 • Number of events 1
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
|
20.0%
2/10 • Number of events 2
|
0.00%
0/11
|
0.00%
0/9
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6
|
0.00%
0/3
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/9
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
0.00%
0/10
|
0.00%
0/11
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/4
|
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