Trial Outcomes & Findings for A First-in-Human Study of LY3009385 in Healthy Participants (NCT NCT01477567)
NCT ID: NCT01477567
Last Updated: 2014-10-06
Results Overview
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline through Day 28
Results posted on
2014-10-06
Participant Flow
Participant milestones
| Measure |
0.3 mg LY3009385
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
5
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First-in-Human Study of LY3009385 in Healthy Participants
Baseline characteristics by cohort
| Measure |
0.3 mg LY3009385
n=5 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 Participants
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
34.6 years
STANDARD_DEVIATION 9.9 • n=10 Participants
|
27.5 years
STANDARD_DEVIATION 4.3 • n=115 Participants
|
33.8 years
STANDARD_DEVIATION 10.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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=10 Participants
|
6 Participants
n=115 Participants
|
40 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
6 Participants
n=115 Participants
|
40 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Singapore
|
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=10 Participants
|
6 participants
n=115 Participants
|
40 participants
n=24 Participants
|
|
Fasting Blood Glucose
|
82.84 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 4.99 • n=5 Participants
|
92.40 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 4.86 • n=7 Participants
|
84.45 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 10.60 • n=5 Participants
|
96.02 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 8.35 • n=4 Participants
|
89.40 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 6.29 • n=21 Participants
|
92.46 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 11.12 • n=10 Participants
|
89.08 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 5.17 • n=115 Participants
|
89.62 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 8.29 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 28Population: All enrolled participants.
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
0.3 mg LY3009385
n=5 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 Participants
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Serious AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Study Drug-Related AEs
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Predose through Day 28Population: Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.
LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized.
Outcome measures
| Measure |
0.3 mg LY3009385
n=3 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=4 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
|
4.81 micrograms times hours per milliliter
Geometric Coefficient of Variation 76
|
9.49 micrograms times hours per milliliter
Geometric Coefficient of Variation 213
|
53.1 micrograms times hours per milliliter
Geometric Coefficient of Variation 54
|
214 micrograms times hours per milliliter
Geometric Coefficient of Variation 42
|
757 micrograms times hours per milliliter
Geometric Coefficient of Variation 59
|
1670 micrograms times hours per milliliter
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Predose through Day 28Population: Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.
The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
Outcome measures
| Measure |
0.3 mg LY3009385
n=4 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax)
|
14.1 nanograms per milliliter
Geometric Coefficient of Variation 41
|
51.9 nanograms per milliliter
Geometric Coefficient of Variation 118
|
180 nanograms per milliliter
Geometric Coefficient of Variation 46
|
847 nanograms per milliliter
Geometric Coefficient of Variation 36
|
2030 nanograms per milliliter
Geometric Coefficient of Variation 14
|
4810 nanograms per milliliter
Geometric Coefficient of Variation 19
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 5, and Day 14Population: Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.
The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Outcome measures
| Measure |
0.3 mg LY3009385
n=5 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 Participants
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Change in Level of Blood Glucose Before and After a Standard Meal
Day 5 (n= 5, 6, 6, 6, 6, 5, 6)
|
76.54 milligrams times hours per deciliter
Standard Deviation 56.51
|
-45.35 milligrams times hours per deciliter
Standard Deviation 18.27
|
-8.44 milligrams times hours per deciliter
Standard Deviation 45.83
|
-14.50 milligrams times hours per deciliter
Standard Deviation 36.92
|
-31.33 milligrams times hours per deciliter
Standard Deviation 38.43
|
-108.93 milligrams times hours per deciliter
Standard Deviation 25.67
|
4.73 milligrams times hours per deciliter
Standard Deviation 30.43
|
|
Change in Level of Blood Glucose Before and After a Standard Meal
Day 14 (n= 0, 0, 6, 6, 6, 5, 4)
|
NA milligrams times hours per deciliter
Standard Deviation NA
The effect of LY3009385 on postprandial glucose concentrations was not evaluated on Day 14 for this treatment arm.
|
NA milligrams times hours per deciliter
Standard Deviation NA
The effect of LY3009385 on postprandial glucose concentrations was not evaluated on Day 14 for this treatment arm.
|
42.30 milligrams times hours per deciliter
Standard Deviation 33.69
|
-60.57 milligrams times hours per deciliter
Standard Deviation 52.29
|
5.16 milligrams times hours per deciliter
Standard Deviation 38.48
|
-129.75 milligrams times hours per deciliter
Standard Deviation 27.55
|
-3.54 milligrams times hours per deciliter
Standard Deviation 54.72
|
SECONDARY outcome
Timeframe: Baseline, Day 5, and Day 14Population: Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.
The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Outcome measures
| Measure |
0.3 mg LY3009385
n=5 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 Participants
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Change in Level of C-peptide Before and After a Standard Meal
Day 5 (n= 5, 6, 6, 6, 6, 5, 6)
|
932.50 picomoles times hours per liter
Standard Deviation 2402.47
|
2235.08 picomoles times hours per liter
Standard Deviation 1204.19
|
982.50 picomoles times hours per liter
Standard Deviation 1104.62
|
1510.58 picomoles times hours per liter
Standard Deviation 1289.05
|
640.25 picomoles times hours per liter
Standard Deviation 1572.44
|
-116.50 picomoles times hours per liter
Standard Deviation 1414.08
|
866.50 picomoles times hours per liter
Standard Deviation 1954.39
|
|
Change in Level of C-peptide Before and After a Standard Meal
Day 14 (n= 0, 0, 6, 6, 6, 5, 4)
|
NA picomoles times hours per liter
Standard Deviation NA
The effect of LY3009385 on postprandial c-peptide levels was not evaluated on Day 14 for this treatment arm.
|
NA picomoles times hours per liter
Standard Deviation NA
The effect of LY3009385 on postprandial c-peptide levels was not evaluated on Day 14 for this treatment arm.
|
-363.92 picomoles times hours per liter
Standard Deviation 1174.13
|
1324.75 picomoles times hours per liter
Standard Deviation 2627.97
|
511.67 picomoles times hours per liter
Standard Deviation 786.06
|
955.40 picomoles times hours per liter
Standard Deviation 1463.97
|
-959.13 picomoles times hours per liter
Standard Deviation 2164.81
|
SECONDARY outcome
Timeframe: Baseline, Day 14Population: Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.
The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.
Outcome measures
| Measure |
0.3 mg LY3009385
n=6 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=5 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=4 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Change in Level of Glucagon Before and After a Standard Meal
|
0.93 picomoles per liter
Standard Deviation 2.66
|
-1.05 picomoles per liter
Standard Deviation 2.59
|
0.68 picomoles per liter
Standard Deviation 2.46
|
0.68 picomoles per liter
Standard Deviation 2.52
|
0.48 picomoles per liter
Standard Deviation 6.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 28Population: Participants who received a dose of LY3009385 or Placebo.
The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.
Outcome measures
| Measure |
0.3 mg LY3009385
n=5 Participants
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 Participants
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 Participants
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 Participants
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 Participants
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 Participants
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 Participants
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Forming Antibody to LY3009385
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
0.3 mg LY3009385
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1 mg LY3009385
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3 mg LY3009385
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
9 mg LY3009385
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
22 mg LY3009385
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
54 mg LY3009385
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.3 mg LY3009385
n=5 participants at risk
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
1 mg LY3009385
n=6 participants at risk
LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
|
3 mg LY3009385
n=6 participants at risk
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
9 mg LY3009385
n=6 participants at risk
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
22 mg LY3009385
n=6 participants at risk
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
54 mg LY3009385
n=5 participants at risk
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
|
Placebo
n=6 participants at risk
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
80.0%
4/5 • Number of events 5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
60.0%
3/5 • Number of events 5
|
0.00%
0/6
|
|
General disorders
Application site erythema
|
0.00%
0/5
|
66.7%
4/6 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Application site pruritus
|
0.00%
0/5
|
50.0%
3/6 • Number of events 4
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Application site rash
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Catheter site erythema
|
20.0%
1/5 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
33.3%
2/6 • Number of events 3
|
|
General disorders
Catheter site haematoma
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site pain
|
20.0%
1/5 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Hunger
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Injection site haematoma
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Injection site pain
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Injection site reaction
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
General disorders
Vessel puncture site thrombosis
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Excoriation
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
100.0%
5/5 • Number of events 10
|
33.3%
2/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
80.0%
4/5 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
100.0%
5/5 • Number of events 14
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/6
|
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