Trial Outcomes & Findings for A Single Dose Study of LY2605541 in Participants With Liver Impairment (NCT NCT01751399)
NCT ID: NCT01751399
Last Updated: 2018-10-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
LY2605541-Normal Hepatic Function
Participants with normal hepatic function received a single subcutaneous (SC) dose of 0.075 milligrams per kilogram (mg/kg) LY2605541
|
LY2605541-Mild Hepatic Impairment
Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Moderate Hepatic Impairment
Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Severe Hepatic Impairment
Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
8
|
7
|
|
Overall Study
Received 1 Dose of Study Drug
|
12
|
8
|
8
|
7
|
|
Overall Study
COMPLETED
|
12
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Dose Study of LY2605541 in Participants With Liver Impairment
Baseline characteristics by cohort
| Measure |
LY2605541-Normal Hepatic Function
n=12 Participants
Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Mild Hepatic Impairment
n=8 Participants
Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Moderate Hepatic Impairment
n=8 Participants
Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Severe Hepatic Impairment
n=7 Participants
Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
56.0 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
52.4 years
STANDARD_DEVIATION 9.9 • n=27 Participants
|
57.6 years
STANDARD_DEVIATION 3.3 • n=483 Participants
|
54.6 years
STANDARD_DEVIATION 6.8 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Participants with Diabetes
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: All participants who received 1 dose of LY2605541 and had evaluable AUC(0-∞) data.
Outcome measures
| Measure |
LY2605541-Normal Hepatic Function
n=12 Participants
Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Mild Hepatic Impairment
n=8 Participants
Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Moderate Hepatic Impairment
n=8 Participants
Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Severe Hepatic Impairment
n=7 Participants
Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541
|
85200 picomole*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 19
|
67200 picomole*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 31
|
64300 picomole*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 65
|
66600 picomole*hours/liter (pmol*h/L)
Geometric Coefficient of Variation 77
|
PRIMARY outcome
Timeframe: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdosePopulation: All participants who received 1 dose of LY2605541 and had evaluable Cmax data.
Outcome measures
| Measure |
LY2605541-Normal Hepatic Function
n=12 Participants
Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Mild Hepatic Impairment
n=8 Participants
Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Moderate Hepatic Impairment
n=8 Participants
Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Severe Hepatic Impairment
n=7 Participants
Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541
|
1300 pmol/L
Geometric Coefficient of Variation 38
|
946 pmol/L
Geometric Coefficient of Variation 73
|
1180 pmol/L
Geometric Coefficient of Variation 163
|
1090 pmol/L
Geometric Coefficient of Variation 119
|
Adverse Events
LY2605541-Normal Hepatic Function
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LY2605541-Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY2605541-Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY2605541-Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2605541-Normal Hepatic Function
n=12 participants at risk
Participants with normal hepatic function received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Mild Hepatic Impairment
n=8 participants at risk
Participants with mild hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Moderate Hepatic Impairment
n=8 participants at risk
Participants with moderate hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
LY2605541-Severe Hepatic Impairment
n=7 participants at risk
Participants with severe hepatic impairment received a single SC dose of 0.075 mg/kg LY2605541
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/7
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Anal abscess
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/7
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/7
|
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