Trial Outcomes & Findings for A Study of LY3185643 and rGlucagon in Healthy Participants (NCT NCT02951780)
NCT ID: NCT02951780
Last Updated: 2019-09-30
Results Overview
Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Results posted on
2019-09-30
Participant Flow
Crossover study with three periods. Each participant received up to 3 doses of study drug (rGlucagon and/or LY3185643) in a dosing day as per the dosing sequence in each period with 7 to 12 days washout period.
Participant milestones
| Measure |
Cohort A (Sequence 1-9-7: 6-4-8: 5-3-2)
LY3185643 and rGlucagon were administered as single subcutaneous (SC) doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 microgram (μg) LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
2
|
3
|
3
|
2
|
3
|
2
|
3
|
2
|
|
Period 1
COMPLETED
|
3
|
2
|
3
|
2
|
2
|
3
|
2
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
3
|
2
|
3
|
2
|
2
|
3
|
2
|
2
|
2
|
|
Period 2
COMPLETED
|
3
|
2
|
3
|
2
|
2
|
3
|
2
|
1
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3
STARTED
|
3
|
2
|
3
|
2
|
2
|
3
|
2
|
1
|
2
|
|
Period 3
COMPLETED
|
3
|
2
|
3
|
2
|
2
|
3
|
2
|
1
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A (Sequence 1-9-7: 6-4-8: 5-3-2)
LY3185643 and rGlucagon were administered as single subcutaneous (SC) doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 microgram (μg) LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Scheduling Conflicts
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
Scheduling Conflicts
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3185643 and rGlucagon in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort A (Sequence 1,9,7: 6,4,8:5,3,2)
n=3 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 1-9-7 in Treatment Period 1, Dosing Sequence: 6-4-8 in Treatment Period 2 and Dosing Sequence: 5-3-2 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )
n=2 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 2-7-8 in Treatment Period 1, Dosing Sequence: 4-5-9 in Treatment Period 2 and Dosing Sequence: 6-1-3 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)
n=3 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 3-8-9 in Treatment Period 1, Dosing Sequence: 5-6-7 in Treatment Period 2 and Dosing Sequence: 4-2-1 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)
n=3 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 4-6-2 in Treatment Period 1, Dosing Sequence: 3-9-1 in Treatment Period 2 and Dosing Sequence: 8-7-5 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)
n=2 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 5-4-3 in Treatment Period 1, Dosing Sequence: 1-7-2 in Treatment Period 2 and Dosing Sequence: 9-8-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)
n=3 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 6-5-1 in Treatment Period 1, Dosing Sequence: 2-8-3 in Treatment Period 2 and Dosing Sequence: 7-9-4 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)
n=2 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 7-1-4 in Treatment Period 1, Dosing Sequence: 9-2-6 in Treatment Period 2 and Dosing Sequence: 9-2-6 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)
n=3 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 8-2-5 in Treatment Period 1, Dosing Sequence: 7-3-4 in Treatment Period 2 and Dosing Sequence: 1-6-9 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )
n=2 Participants
LY3185643 and rGlucagon were administered as single SC doses with Dosing Sequence 9-3-6 in Treatment Period 1, Dosing Sequence: 8-1-5 in Treatment Period 2 and Dosing Sequence: 2-4-7 in Treatment Period 3.
Dose assignment was: Dose 1 = 10 μg LY3185643; Dose 2 = 25 μg LY3185643; Dose 3 = 50 μg LY3185643; Dose 4 = 100 μg LY3185643; Dose 5 = 200 μg LY3185643; Dose 6 = 10 μg rGlucagon; Dose 7 = 25 μg rGlucagon; Dose 8 = 50 μg rGlucagon; Dose 9 = 200 μg rGlucagon.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Region of Enrollment
Singapore
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data.
Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
Outcome measures
| Measure |
10 ug LY3185643
n=19 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=19 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
|
191 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 49
|
658 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 36
|
1110 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 40
|
2010 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 40
|
3830 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 38
|
53.7 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 31
|
204 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 70
|
283 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 44
|
897 picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data.
Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.
Outcome measures
| Measure |
10 ug LY3185643
n=4 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=19 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=18 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=15 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=19 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=15 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
|
356 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 30
|
1200 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 21
|
2230 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 21
|
4430 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 21
|
9120 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 17
|
NA picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation NA
AUC(0-inf) could not be calculated because of several PK samples were below the quantification limit.
|
189 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 57
|
249 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 24
|
764 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.
Cmax was assessed for LY3185643 and rGlucagon.
Outcome measures
| Measure |
10 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=23 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
|
5.54 milligram per deciliter (mg/dL)
Standard Deviation 2.66
|
15.1 milligram per deciliter (mg/dL)
Standard Deviation 9.94
|
24.0 milligram per deciliter (mg/dL)
Standard Deviation 16.6
|
37.1 milligram per deciliter (mg/dL)
Standard Deviation 20.6
|
53.2 milligram per deciliter (mg/dL)
Standard Deviation 17.7
|
4.37 milligram per deciliter (mg/dL)
Standard Deviation 3.39
|
12.5 milligram per deciliter (mg/dL)
Standard Deviation 11.1
|
16.9 milligram per deciliter (mg/dL)
Standard Deviation 11.4
|
38.1 milligram per deciliter (mg/dL)
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.
Cmax was assessed for C-peptide of LY3185643 and rGlucagon
Outcome measures
| Measure |
10 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=23 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
|
50.2 picomole per liter (pmol/L)
Standard Deviation 44.7
|
201 picomole per liter (pmol/L)
Standard Deviation 168
|
324 picomole per liter (pmol/L)
Standard Deviation 330
|
555 picomole per liter (pmol/L)
Standard Deviation 387
|
969 picomole per liter (pmol/L)
Standard Deviation 451
|
25.4 picomole per liter (pmol/L)
Standard Deviation 34.1
|
119 picomole per liter (pmol/L)
Standard Deviation 98.9
|
218 picomole per liter (pmol/L)
Standard Deviation 154
|
577 picomole per liter (pmol/L)
Standard Deviation 292
|
PRIMARY outcome
Timeframe: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (LY3185643, C-peptide) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.
Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for LY3185643 and rGlucagon.
Outcome measures
| Measure |
10 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=23 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
|
1.46 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 7.52
|
18.9 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 15.3
|
29.7 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 21.1
|
45.1 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 27.1
|
71.5 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 37.8
|
0.594 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 11.9
|
7.74 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 15.6
|
12.1 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 14.4
|
24.0 milligram*hour per deciliter (mg*hr/dL)
Standard Deviation 15.8
|
PRIMARY outcome
Timeframe: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dosePopulation: All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.
Area under the concentration versus time curve from time zero to 3 hours \[AUC (0-3)\] was assessed for C-peptide of LY3185643 and rGlucagon.
Outcome measures
| Measure |
10 ug LY3185643
n=20 Participants
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=23 Participants
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=21 Participants
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=22 Participants
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 Participants
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 Participants
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 Participants
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
|
25.0 picomole*hour per liter (pmol*h/L)
Standard Deviation 60.5
|
246 picomole*hour per liter (pmol*h/L)
Standard Deviation 194
|
354 picomole*hour per liter (pmol*h/L)
Standard Deviation 388
|
669 picomole*hour per liter (pmol*h/L)
Standard Deviation 441
|
1170 picomole*hour per liter (pmol*h/L)
Standard Deviation 529
|
-28.3 picomole*hour per liter (pmol*h/L)
Standard Deviation 82.2
|
82.1 picomole*hour per liter (pmol*h/L)
Standard Deviation 130
|
167 picomole*hour per liter (pmol*h/L)
Standard Deviation 162
|
626 picomole*hour per liter (pmol*h/L)
Standard Deviation 325
|
Adverse Events
10 ug LY3185643
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
25 ug LY3185643
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 ug LY3185643
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 ug LY3185643
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
200 ug LY3185643
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 ug rGlucagon
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 ug rGlucagon
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 ug rGlucagon
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 ug rGlucagon
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 ug LY3185643
n=20 participants at risk
LY3185643 has been administered SC as single dose of 10 ug.
|
25 ug LY3185643
n=23 participants at risk
LY3185643 has been administered SC as single dose of 25 ug.
|
50 ug LY3185643
n=21 participants at risk
LY3185643 has been administered SC as single dose of 50 ug.
|
100 ug LY3185643
n=22 participants at risk
LY3185643 has been administered SC as single dose of 100 ug.
|
200 ug LY3185643
n=22 participants at risk
LY3185643 has been administered SC as single dose of 200 ug.
|
10 ug rGlucagon
n=21 participants at risk
rGlucagon has been administered SC as single dose of 10 ug.
|
25 ug rGlucagon
n=21 participants at risk
rGlucagon has been administered SC as single dose of 25 ug.
|
50 ug rGlucagon
n=22 participants at risk
rGlucagon has been administered SC as single dose of 50 ug.
|
200 ug rGlucagon
n=20 participants at risk
rGlucagon has been administered SC as single dose of 200 ug.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.3%
1/23 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Administration site bruise
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.3%
1/23 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Asthenia
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Injection site pain
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Injection site rash
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Injection site reaction
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
General disorders
Thirst
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.3%
1/23 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
9.1%
2/22 • Number of events 2 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
5.0%
1/20 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.8%
1/21 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/23 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/22 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/21 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
4.5%
1/22 • Number of events 1 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
0.00%
0/20 • Up To 3 Months
All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER