Trial Outcomes & Findings for A Study of LY2605541 in Healthy Participants (NCT NCT01877265)
NCT ID: NCT01877265
Last Updated: 2018-10-19
Results Overview
LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized for each PEG source (LY1, LY2, or LY3).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period
Results posted on
2018-10-19
Participant Flow
LY2605541 was manufactured using the 3 different polyethylene glycol (PEG) sources (referred to as Source 1 \[LY1\], Source 2 \[LY2\], and Source 3 \[LY3\]). Participants were randomized to 1 of 6 treatment sequences and received a single injection of LY1, LY2, or LY3 on Day 1 of each of 3 treatment periods according to their assigned treatment sequence.
Participant milestones
| Measure |
LY3/LY2/LY1
A single, subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) LY2605541 from Source 3 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY2/LY1/LY3
A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY1/LY2/LY3
A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY1/LY3/LY2
A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY3/LY1/LY2
A single, SC injection of 0.5 U/kg LY2605541 from Source 3 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY2/LY3/LY1
A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment Period 1
Received at Least One Dose of Study Drug
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment Period 1
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (at Least 14 Days)
STARTED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Washout Period 1 (at Least 14 Days)
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Washout Period 1 (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Treatment Period 2
Received at Least One Dose of Study Drug
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Treatment Period 2
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (at Least 14 Days)
STARTED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Washout Period 2 (at Least 14 Days)
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
2
|
|
Washout Period 2 (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
STARTED
|
3
|
3
|
2
|
3
|
3
|
2
|
|
Treatment Period 3
Received at Least One Dose of Study Drug
|
3
|
3
|
2
|
3
|
3
|
2
|
|
Treatment Period 3
COMPLETED
|
2
|
3
|
2
|
3
|
3
|
2
|
|
Treatment Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY3/LY2/LY1
A single, subcutaneous (SC) injection of 0.5 units per kilogram (U/kg) LY2605541 from Source 3 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY2/LY1/LY3
A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY1/LY2/LY3
A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 2 on Day 1 of Period 2; and from Source 3 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY1/LY3/LY2
A single, SC injection of 0.5 U/kg LY2605541 from Source 1 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY3/LY1/LY2
A single, SC injection of 0.5 U/kg LY2605541 from Source 3 on Day 1 of Period 1; from Source 1 on Day 1 of Period 2; and from Source 2 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
LY2/LY3/LY1
A single, SC injection of 0.5 U/kg LY2605541 from Source 2 on Day 1 of Period 1; from Source 3 on Day 1 of Period 2; and from Source 1 on Day 1 of Period 3.
There was a washout period of at least 14 days between injections. Each participant received up to 3 injections.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Sponsor Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 2 (at Least 14 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2605541 in Healthy Participants
Baseline characteristics by cohort
| Measure |
0.5 U/kg LY2605541
n=18 Participants
Participants randomized to receive a single, SC injection of 0.5 U/kg LY2605541 using 3 different PEG sources on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence.
|
|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each periodPopulation: Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data.
LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized for each PEG source (LY1, LY2, or LY3).
Outcome measures
| Measure |
0.5 U/kg LY2605541 (LY1)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 1 (LY1) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY2)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY3)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
|
128000 picomoles times hours per liter
Geometric Coefficient of Variation 23
|
145000 picomoles times hours per liter
Geometric Coefficient of Variation 22
|
135000 picomoles times hours per liter
Geometric Coefficient of Variation 18
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each periodPopulation: Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data.
The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3).
Outcome measures
| Measure |
0.5 U/kg LY2605541 (LY1)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 1 (LY1) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY2)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY3)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
|
1980 picomoles per liter
Geometric Coefficient of Variation 39
|
2490 picomoles per liter
Geometric Coefficient of Variation 35
|
2210 picomoles per liter
Geometric Coefficient of Variation 39
|
SECONDARY outcome
Timeframe: Predose and up to 24 hours post dose in each periodPopulation: Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data.
The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).
Outcome measures
| Measure |
0.5 U/kg LY2605541 (LY1)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 1 (LY1) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY2)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY3)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods.
|
|---|---|---|---|
|
Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
|
1.21 milligrams per minute per kilogram
Geometric Coefficient of Variation 37
|
1.31 milligrams per minute per kilogram
Geometric Coefficient of Variation 57
|
1.40 milligrams per minute per kilogram
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: Predose and up to 24 hours post dose in each periodPopulation: Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data.
The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).
Outcome measures
| Measure |
0.5 U/kg LY2605541 (LY1)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 1 (LY1) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY2)
n=17 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 2 (LY2) on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY3)
n=16 Participants
LY2605541: 0.5 U/kg SC injection, single dose from PEG source 3 (LY3) on Day 1 of 1 of the 3 treatment periods.
|
|---|---|---|---|
|
Glucodynamics: Total Amount of Glucose Infused (Gtot)
|
900 milligrams per kilogram
Geometric Coefficient of Variation 53
|
963 milligrams per kilogram
Geometric Coefficient of Variation 103
|
1190 milligrams per kilogram
Geometric Coefficient of Variation 49
|
Adverse Events
0.5 U/kg LY2605541 (LY1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.5 U/kg LY2605541 (LY2)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.5 U/kg LY2605541 (LY3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5 U/kg LY2605541 (LY1)
n=17 participants at risk
LY2605541: 0.5 U/kg SC injection, single dose from LY1 on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY2)
n=17 participants at risk
LY2605541: 0.5 U/kg SC injection, single dose from LY2 on Day 1 of 1 of the 3 treatment periods.
|
0.5 U/kg LY2605541 (LY3)
n=17 participants at risk
LY2605541: 0.5 U/kg SC injection, single dose from LY3 on Day 1 of 1 of the 3 treatment periods.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Catheter site pain
|
5.9%
1/17 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
General disorders
Catheter site swelling
|
5.9%
1/17 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
0.00%
0/17
|
|
Nervous system disorders
Tremor
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
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