Trial Outcomes & Findings for A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol (NCT NCT01426412)
NCT ID: NCT01426412
Last Updated: 2019-04-05
Results Overview
Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
Baseline to study completion (up to 22 weeks)
Results posted on
2019-04-05
Participant Flow
Participant milestones
| Measure |
0.03 mg/kg LY3015014 IV
A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV).
|
0.1 mg/kg LY3015014 IV
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
Placebo
A single dose of placebo administered IV or SC with a statin add-on dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
17
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
17
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
5
|
6
|
6
|
7
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
0.03 mg/kg LY3015014 IV
A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV).
|
0.1 mg/kg LY3015014 IV
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
Placebo
A single dose of placebo administered IV or SC with a statin add-on dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
1
|
Baseline Characteristics
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
Baseline characteristics by cohort
| Measure |
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 milligrams per kilogram (mg/kg) LY3015014 administered intravenously (IV).
|
0.1 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered subcutaneously (SC) with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=10 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
Placebo
n=17 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 13.9 • n=21 Participants
|
44.3 years
STANDARD_DEVIATION 14.1 • n=8 Participants
|
53.3 years
STANDARD_DEVIATION 4.1 • n=8 Participants
|
52.5 years
STANDARD_DEVIATION 12.0 • n=24 Participants
|
48.5 years
STANDARD_DEVIATION 12.8 • n=42 Participants
|
49.1 years
STANDARD_DEVIATION 12.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 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=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=24 Participants
|
5 participants
n=42 Participants
|
69 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion (up to 22 weeks)Population: All randomized participants.
Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=10 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
10.0 mg/kg LY3015014 IV Non-Japanese
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Effects
AE
|
13 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dosePopulation: All randomized participants who received LY3015014 and had PK data to calculate AUC(0-tlast).
Outcome measures
| Measure |
Placebo
n=6 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=5 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=5 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=4 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
10.0 mg/kg LY3015014 IV Non-Japanese
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration of LY3015014 [AUC(0-tlast)]
|
109 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 9
|
435 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 16
|
1450 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 20
|
5610 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 22
|
18600 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 17
|
89100 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 17
|
57500 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 62
|
12700 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 39
|
11700 micrograms *hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dosePopulation: All randomized participants who received LY3015014 and had PK data to calculate Cmax.
Outcome measures
| Measure |
Placebo
n=6 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=5 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=5 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=4 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
10.0 mg/kg LY3015014 IV Non-Japanese
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY3015014
|
1.18 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 16
|
3.18 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 7
|
11.0 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 18
|
29.2 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
97.3 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 27
|
312 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 18
|
282 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 9
|
24.8 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25
|
19.8 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 15 and 29Population: All randomized participants with evaluable LDL-C data at specified time points.
Least Square means were calculated using mixed-effects models for repeated measures analysis. The model included factors for treatment, visits and baseline LDL-C. Percent change = (LDL value on Days 15 or 29 - LDL at baseline) / LDL at baseline \*100.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=4 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
10.0 mg/kg LY3015014 IV Non-Japanese
n=6 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Day 15
|
-1.69 percentage of change
Interval -6.56 to 3.19
|
-11.55 percentage of change
Interval -19.79 to -3.32
|
-17.49 percentage of change
Interval -25.7 to -9.27
|
-40.34 percentage of change
Interval -48.56 to -32.12
|
-34.84 percentage of change
Interval -43.08 to -26.59
|
-57.00 percentage of change
Interval -65.21 to -48.79
|
-53.56 percentage of change
Interval -61.78 to -45.34
|
-56.58 percentage of change
Interval -64.83 to -48.33
|
-47.31 percentage of change
Interval -58.35 to -36.28
|
-50.83 percentage of change
Interval -59.03 to -42.62
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Day 29
|
-2.88 percentage of change
Interval -7.75 to 2.0
|
-6.17 percentage of change
Interval -14.89 to 2.55
|
-13.01 percentage of change
Interval -21.22 to -4.8
|
-31.83 percentage of change
Interval -40.05 to -23.6
|
-34.90 percentage of change
Interval -43.15 to -26.65
|
-54.40 percentage of change
Interval -62.61 to -46.19
|
-51.63 percentage of change
Interval -59.85 to -43.4
|
-58.02 percentage of change
Interval -66.27 to -49.76
|
-39.31 percentage of change
Interval -52.51 to -26.1
|
-58.08 percentage of change
Interval -66.28 to -49.87
|
SECONDARY outcome
Timeframe: Days 8, 29 and 85Population: All randomized participants.
Outcome measures
| Measure |
Placebo
n=17 Participants
A single dose of placebo administered IV or SC with a statin add-on dose.
|
0.03 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=6 Participants
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 Participants
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=10 Participants
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
10.0 mg/kg LY3015014 IV Non-Japanese
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies
Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies
Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
0.03 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.1 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.3 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1.0 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3.0 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3.0 mg/kg LY3015014 SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3.0 mg/kg LY3015014 SC +Statin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10.0 mg/kg LY3015014 IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.03 mg/kg LY3015014 IV
n=6 participants at risk
A single dose of 0.03 mg/kg LY3015014 administered IV.
|
0.1 mg/kg LY3015014 IV
n=6 participants at risk
A single dose of 0.1 mg/kg LY3015014 administered IV.
|
0.3 mg/kg LY3015014 IV
n=6 participants at risk
A single dose of 0.3 mg/kg LY3015014 administered IV.
|
1.0 mg/kg LY3015014 IV
n=6 participants at risk
A single dose of 1.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 IV
n=6 participants at risk
A single dose of 3.0 mg/kg LY3015014 administered IV.
|
3.0 mg/kg LY3015014 SC
n=6 participants at risk
A single dose of 3.0 mg/kg LY3015014 administered SC.
|
3.0 mg/kg LY3015014 SC +Statin
n=6 participants at risk
A single dose of 3.0 mg/kg LY3015014 administered SC with a statin add-on dose.
|
10.0 mg/kg LY3015014 IV
n=10 participants at risk
A single dose of 10.0 mg/kg LY3015014 administered IV to non-Japanese or Japanese participants.
|
Placebo
n=17 participants at risk
A single dose of placebo administered IV or SC with a statin add-on dose.
|
|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Eye disorders
Photophobia
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
23.5%
4/17 • Number of events 5 • Up To 22 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
11.8%
2/17 • Number of events 2 • Up To 22 weeks
|
|
General disorders
Application site erythema
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
General disorders
Application site irritation
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
General disorders
Catheter site haematoma
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • Up To 22 weeks
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
23.5%
4/17 • Number of events 4 • Up To 22 weeks
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Up To 22 weeks
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Investigations
Electrocardiogram pr prolongation
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
5.9%
1/17 • Number of events 1 • Up To 22 weeks
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
23.5%
4/17 • Number of events 5 • Up To 22 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Nervous system disorders
Sinus headache
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
10.0%
1/10 • Number of events 1 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
16.7%
1/6 • Number of events 1 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
|
Surgical and medical procedures
Sinus operation
|
33.3%
2/6 • Number of events 2 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/6 • Up To 22 weeks
|
0.00%
0/10 • Up To 22 weeks
|
0.00%
0/17 • Up To 22 weeks
|
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