Trial Outcomes & Findings for A Study of LY3143753 and LY3185643 in Healthy Participants (NCT NCT02342314)
NCT ID: NCT02342314
Last Updated: 2019-03-13
Results Overview
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Baseline to Study Completion (Up to 84 Days)
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Placebo (Part A)
Single subcutaneous (SC) injection of normal saline on Day 1.
|
0.05 mg of LY3143753 (Part A)
Part A: 0.05 milligram (mg) of LY3143753 given as a single SC injection on Day 1.
|
0.1 mg of LY3143753 (Part A)
Part A: 0.1 mg of LY3143753 given as a single SC injection on Day 1.
|
0.2 mg of LY3143753 (Part A)
Part A: 0.2 mg of LY3143753 given as a single SC injection on Day 1.
|
0.4 mg of LY3143753 (Part A)
Part A: 0.4 mg of LY3143753 given as a single SC injection on Day 1.
|
1.0 mg of LY3143753 (Part A)
Part A: 1.0 mg of LY3143753 given as a SC injection on Day 1.
|
Placebo (Part B)
Part B: Single SC injection of normal saline on Day 1.
|
0.01 mg of LY3185643 (Part B)
Part B: 0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
Part B: 0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
Part B: 0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
Part B: 0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
Part B: 0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
Part B: 0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
Part B: 0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
0.48 mg of LY3185643 (Part B)
Part B: 0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
Part B: 0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
rGlucagon (Part B)
Part B: 1.0 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
|
Part A
STARTED
|
6
|
3
|
3
|
3
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
6
|
3
|
3
|
3
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3143753 and LY3185643 in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY3143753 (Part A)
n=24 Participants
Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1.
|
LY3185643 (Part B)
n=44 Participants
Single SC injection of ascending doses of LY3185643 on Day 1.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (Up to 84 Days)Population: All randomized participants who received at least one dose of study drug.
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=11 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 Participants
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=3 Participants
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
n=3 Participants
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
n=3 Participants
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
n=3 Participants
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
n=3 Participants
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
n=3 Participants
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
n=6 Participants
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=6 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A
|
0.726 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 81
|
1.05 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
2.95 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
5.73 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
11.4 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Cmax of Part B
|
0.126 ng/mL
Geometric Coefficient of Variation 12
|
0.367 ng/mL
Geometric Coefficient of Variation 51
|
1.19 ng/mL
Geometric Coefficient of Variation 70
|
0.951 ng/mL
Geometric Coefficient of Variation 32
|
2.34 ng/mL
Geometric Coefficient of Variation 48
|
4.25 ng/mL
Geometric Coefficient of Variation 53
|
4.67 ng/mL
Geometric Coefficient of Variation 51
|
6.49 ng/mL
Geometric Coefficient of Variation 58
|
9.67 ng/mL
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=6 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A
|
1.44 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
1.57 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 97
|
5.76 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
12.6 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
22.6 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: AUC(0-∞) of Part B
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
PK data from 3 participants at this lowest LY3185643 dose was very limited with few measurable data points which led to the inability to estimate the AUC(0-infinity) PK parameter.
|
0.564 ng*hr/mL
Geometric Coefficient of Variation 8
|
2.61 ng*hr/mL
Geometric Coefficient of Variation 42
|
1.34 ng*hr/mL
Geometric Coefficient of Variation 24
|
3.73 ng*hr/mL
Geometric Coefficient of Variation 22
|
8.87 ng*hr/mL
Geometric Coefficient of Variation 18
|
10.8 ng*hr/mL
Geometric Coefficient of Variation 14
|
16.2 ng*hr/mL
Geometric Coefficient of Variation 55
|
21.5 ng*hr/mL
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=6 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Time to Maximum Drug Concentration (Tmax) of Part A
|
0.67 hour
Interval 0.67 to 1.0
|
0.83 hour
Interval 0.33 to 1.0
|
0.67 hour
Interval 0.67 to 0.67
|
1.04 hour
Interval 0.67 to 1.5
|
1.25 hour
Interval 0.67 to 1.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Tmax of Part B
|
0.83 hour
Interval 0.83 to 0.83
|
0.67 hour
Interval 0.5 to 1.0
|
0.83 hour
Interval 0.83 to 1.0
|
0.67 hour
Interval 0.55 to 0.83
|
0.50 hour
Interval 0.5 to 1.0
|
1.25 hour
Interval 1.0 to 1.25
|
1.23 hour
Interval 0.83 to 1.25
|
1.75 hour
Interval 0.67 to 1.75
|
0.83 hour
Interval 0.67 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All participants who received at least one dose of study drug or placebo and have evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A
|
101 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 10
|
168 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 26
|
197 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 17
|
179 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 13
|
188 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 10
|
177 milligram/deciliter (mg/dL)
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All participants who received at least one dose of study drug or placebo and have evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=11 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 Participants
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=6 Participants
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD Absolute Maximum Blood Glucose of Part B
|
95.1 mg/dL
Geometric Coefficient of Variation 5
|
103 mg/dL
Geometric Coefficient of Variation 11
|
98.1 mg/dL
Geometric Coefficient of Variation 10
|
128 mg/dL
Geometric Coefficient of Variation 36
|
117 mg/dL
Geometric Coefficient of Variation 7
|
167 mg/dL
Geometric Coefficient of Variation 16
|
186 mg/dL
Geometric Coefficient of Variation 7
|
146 mg/dL
Geometric Coefficient of Variation 16
|
192 mg/dL
Geometric Coefficient of Variation 16
|
188 mg/dL
Geometric Coefficient of Variation 3
|
162 mg/dL
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=5 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD: Maximum Glucose Increase (Gmax) of Part A
|
4.14 mg/dL
Geometric Coefficient of Variation 112
|
66.1 mg/dL
Geometric Coefficient of Variation 63
|
103 mg/dL
Geometric Coefficient of Variation 17
|
84.9 mg/dL
Geometric Coefficient of Variation 18
|
91.5 mg/dL
Geometric Coefficient of Variation 20
|
79.8 mg/dL
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=10 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=2 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 Participants
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=6 Participants
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD: Gmax of Part B
|
4.69 mg/dL
Geometric Coefficient of Variation 54
|
7.2 mg/dL
Geometric Coefficient of Variation 12.6
|
5.04 mg/dL
Geometric Coefficient of Variation 189
|
28.1 mg/dL
Geometric Coefficient of Variation 144
|
21.8 mg/dL
Geometric Coefficient of Variation 66
|
76.1 mg/dL
Geometric Coefficient of Variation 35
|
89.4 mg/dL
Geometric Coefficient of Variation 14
|
58.4 mg/dL
Geometric Coefficient of Variation 35
|
102 mg/dL
Geometric Coefficient of Variation 25
|
105 mg/dL
Geometric Coefficient of Variation 6
|
71.8 mg/dL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD: Time to Maximum Blood Glucose (Gtmax) of Part A
|
0.96 hour
Interval 0.0 to 4.0
|
1.00 hour
Interval 0.75 to 1.0
|
1.00 hour
Interval 0.58 to 1.0
|
0.67 hour
Interval 0.5 to 0.67
|
0.79 hour
Interval 0.75 to 2.5
|
0.58 hour
Interval 0.5 to 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable PD data.
Outcome measures
| Measure |
Placebo (Part A)
n=11 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 Participants
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=6 Participants
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PD: Gtmax of Part B
|
0.5 hour
Interval 0.0 to 1.5
|
0.5 hour
Interval 0.0 to 0.5
|
0.67 hour
Interval 0.25 to 0.83
|
1.0 hour
Interval 0.83 to 1.33
|
0.67 hour
Interval 0.67 to 0.75
|
0.75 hour
Interval 0.75 to 1.17
|
1.17 hour
Interval 0.92 to 1.33
|
0.58 hour
Interval 0.5 to 0.75
|
1.17 hour
Interval 0.83 to 1.33
|
0.75 hour
Interval 0.67 to 1.0
|
0.46 hour
Interval 0.33 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8 hours after drug administrationPopulation: All randomized participants who received at least one dose of study drug and who had evaluable QTcF data.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=2 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=2 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=5 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A
|
0.6 milliseconds (msec)
Standard Deviation 6.4
|
NA milliseconds (msec)
Standard Deviation NA
Data was not available for one participant at each of these time points so the mean and standard deviation (SD) were not applicable.
|
0.2 milliseconds (msec)
Standard Deviation 18.6
|
NA milliseconds (msec)
Standard Deviation NA
Data was not available for one participant at each of these time points so the mean and SD were not applicable.
|
6.1 milliseconds (msec)
Standard Deviation 14.5
|
6.1 milliseconds (msec)
Standard Deviation 13.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8 hours after drug administrationPopulation: All randomized participants who received at least one dose of study drug and had evaluable QTcF data.
Outcome measures
| Measure |
Placebo (Part A)
n=9 Participants
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 Participants
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 Participants
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 Participants
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=3 Participants
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 Participants
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=3 Participants
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 Participants
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 Participants
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=2 Participants
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=6 Participants
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
QTcF Change From Baseline of Part B
|
-1.4 milliseconds (msec)
Standard Deviation 8.3
|
-2.9 milliseconds (msec)
Standard Deviation 8.5
|
-10.2 milliseconds (msec)
Standard Deviation 3.3
|
-5.9 milliseconds (msec)
Standard Deviation 12.5
|
-4.1 milliseconds (msec)
Standard Deviation 7.8
|
0.5 milliseconds (msec)
Standard Deviation 11.3
|
-4.7 milliseconds (msec)
Standard Deviation 7.6
|
2.5 milliseconds (msec)
Standard Deviation 13.0
|
-2.1 milliseconds (msec)
Standard Deviation 2.7
|
NA milliseconds (msec)
Standard Deviation NA
Data was not available for one participant at each of these time points so the mean and SD were not applicable.
|
-7.7 milliseconds (msec)
Standard Deviation 5.8
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.05 mg of LY3143753 (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.1 mg of LY3143753 (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.2 mg of LY3143753 (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.4 mg of LY3143753 (Part A)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
1 mg of LY3143753 (Part A)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
0.01 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.03 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.05 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.06 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.1 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.2 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.3 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B 0.48 mg of LY3185643
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.72 mg of LY3185643 (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
r Glucagon (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=6 participants at risk
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 participants at risk
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 participants at risk
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 participants at risk
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 participants at risk
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 participants at risk
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=11 participants at risk
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 participants at risk
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 participants at risk
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 participants at risk
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=3 participants at risk
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
n=3 participants at risk
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
n=3 participants at risk
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
n=3 participants at risk
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
n=3 participants at risk
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
n=3 participants at risk
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
n=6 participants at risk
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
Other adverse events
| Measure |
Placebo (Part A)
n=6 participants at risk
Single SC injection on Day 1.
|
0.05 mg of LY3143753 (Part A)
n=3 participants at risk
0.05 mg of LY3143753 given as a single SC injection.
|
0.1 mg of LY3143753 (Part A)
n=3 participants at risk
0.1 mg of LY3143753 given as a single SC injection.
|
0.2 mg of LY3143753 (Part A)
n=3 participants at risk
0.2 mg of LY3143753 given as a single SC injection.
|
0.4 mg of LY3143753 (Part A)
n=6 participants at risk
0.4 mg of LY3143753 given as a single SC injection.
|
1 mg of LY3143753 (Part A)
n=3 participants at risk
1 mg of LY3143753 given as a single SC injection.
|
Placebo (Part B)
n=11 participants at risk
Single SC injection on Day 1.
|
0.01 mg of LY3185643 (Part B)
n=3 participants at risk
0.01 mg of LY3185643 given as a single SC injection on Day 1.
|
0.03 mg of LY3185643 (Part B)
n=3 participants at risk
0.03 mg of LY3185643 given as a single SC injection on Day 1.
|
0.05 mg of LY3185643 (Part B)
n=3 participants at risk
0.05 mg of LY3185643 given as a single SC injection on Day 1.
|
0.06 mg of LY3185643 (Part B)
n=3 participants at risk
0.06 mg of LY3185643 given as a single SC injection on Day 1.
|
0.1 mg of LY3185643 (Part B)
n=3 participants at risk
0.1 mg of LY3185643 given as a single SC injection on Day 1.
|
0.2 mg of LY3185643 (Part B)
n=3 participants at risk
0.2 mg of LY3185643 given as a single SC injection on Day 1.
|
0.3 mg of LY3185643 (Part B)
n=3 participants at risk
0.3 mg of LY3185643 given as a single SC injection on Day 1.
|
Part B 0.48 mg of LY3185643
n=3 participants at risk
0.48 mg of LY3185643 given as a single SC injection on Day 1.
|
0.72 mg of LY3185643 (Part B)
n=3 participants at risk
0.72 mg of LY3185643 given as a single SC injection on Day 1.
|
r Glucagon (Part B)
n=6 participants at risk
1 mg of rGlucagon given as a single SC injection. (Part B).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
100.0%
3/3 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Feeling hot
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Injection site erythema
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
General disorders
Thirst
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Immune system disorders
Seasonal allergy
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Cystitis
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/11
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 5
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
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
Restriction type: GT60