Trial Outcomes & Findings for A Study of LY2605541 in Healthy Participants and in the Elderly (NCT NCT01818245)
NCT ID: NCT01818245
Last Updated: 2018-10-16
Results Overview
AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
LY2605541: Cohort A (Participants ≤55 Years of Age)
Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout.
Intervention A: participants ≤55 years of age received 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 of the treatment period.
Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period.
Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period.
|
LY2605541: Cohort B (Participants ≥65 Years of Age)
Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
|
|---|---|---|
|
Intervention A
STARTED
|
30
|
22
|
|
Intervention A
Received One Dose of Study Drug
|
30
|
22
|
|
Intervention A
COMPLETED
|
30
|
22
|
|
Intervention A
NOT COMPLETED
|
0
|
0
|
|
Washout (16-28 Days)
STARTED
|
30
|
0
|
|
Washout (16-28 Days)
COMPLETED
|
30
|
0
|
|
Washout (16-28 Days)
NOT COMPLETED
|
0
|
0
|
|
Intervention B
STARTED
|
30
|
0
|
|
Intervention B
COMPLETED
|
30
|
0
|
|
Intervention B
NOT COMPLETED
|
0
|
0
|
|
Intervention C
STARTED
|
30
|
0
|
|
Intervention C
COMPLETED
|
30
|
0
|
|
Intervention C
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY2605541 in Healthy Participants and in the Elderly
Baseline characteristics by cohort
| Measure |
LY2605541: Cohort A (Participants ≤55 Years of Age)
n=30 Participants
Participants ≤55 years of age were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 16-28 day washout.
Intervention A: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 of the treatment period.
Intervention B: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 of the treatment period.
Intervention C: participants ≤55 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 of the treatment period.
|
LY2605541: Cohort B (Participants ≥65 Years of Age)
n=22 Participants
Participants ≥65 years of age received 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 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
|
0 Participants
n=7 Participants
|
1 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
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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 States
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: Participants in Cohort A who received LY2605541 and had evaluable AUC(0-∞) data.
AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
|
124000 picomoles*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 37
|
133000 picomoles*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 39
|
135000 picomoles*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 36
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: Participants in Cohort A who received LY2605541 and had evaluable Cmax data.
Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
|
1839.17 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 59
|
1700.68 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 54
|
2027.99 picomoles/liter (pmol/L)
Geometric Coefficient of Variation 66
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable AUC(0-∞) data.
AUC(0-∞) for LY2605541 was evaluated.
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=22 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
|
124000 pmol*h/L
Geometric Coefficient of Variation 37
|
134000 pmol*h/L
Geometric Coefficient of Variation 30
|
—
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable Cmax data.
Cmax of LY2605541 was evaluated.
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=22 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
|
1839.17 pmol/L
Geometric Coefficient of Variation 59
|
1829.92 pmol/L
Geometric Coefficient of Variation 49
|
—
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post clamp procedure in all treatment periodsPopulation: Participants in Cohort A who received LY2605541 and had evaluable Gtot data.
Gtot was evaluated across injection sites (abdominal wall, arm, and thigh).
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=29 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
n=29 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
|
674 milligrams/kilograms (mg/kg)
Geometric Coefficient of Variation 109
|
633 milligrams/kilograms (mg/kg)
Geometric Coefficient of Variation 102
|
454 milligrams/kilograms (mg/kg)
Geometric Coefficient of Variation 204
|
SECONDARY outcome
Timeframe: Predose up to 24 hours post clamp procedure in all treatment periodsPopulation: Participants in Cohort A who received LY2605541 and had evaluable Rmax data.
Rmax was evaluated across injection sites (abdominal wall, arm, and thigh).
Outcome measures
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=29 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=30 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
n=29 Participants
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
|---|---|---|---|
|
Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
|
0.944 milligrams/minute/kilogram (mg/min/kg)
Geometric Coefficient of Variation 88
|
0.935 milligrams/minute/kilogram (mg/min/kg)
Geometric Coefficient of Variation 83
|
0.738 milligrams/minute/kilogram (mg/min/kg)
Geometric Coefficient of Variation 144
|
Adverse Events
LY2605541: Cohort A (Injection Site: Abdomen)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2605541: Cohort A (Injection Site: Upper Arm)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LY2605541: Cohort A (Injection Site: Thigh)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2605541: Cohort B (Injection Site: Abdomen)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2605541: Cohort A (Injection Site: Abdomen)
n=30 participants at risk
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Upper Arm)
n=30 participants at risk
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort A (Injection Site: Thigh)
n=30 participants at risk
Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods.
|
LY2605541: Cohort B (Injection Site: Abdomen)
n=22 participants at risk
Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/30
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Catheter site pain
|
3.3%
1/30 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
13.3%
4/30 • Number of events 4
|
0.00%
0/22
|
|
General disorders
Catheter site swelling
|
0.00%
0/30
|
3.3%
1/30 • Number of events 1
|
20.0%
6/30 • Number of events 7
|
0.00%
0/22
|
|
General disorders
Chest discomfort
|
0.00%
0/30
|
0.00%
0/30
|
6.7%
2/30 • Number of events 2
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30
|
0.00%
0/30
|
0.00%
0/30
|
9.1%
2/22 • Number of events 2
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
13.6%
3/22 • Number of events 3
|
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