Trial Outcomes & Findings for A Study of LY3015014 in Healthy Participants With High Cholesterol (NCT NCT01671085)
NCT ID: NCT01671085
Last Updated: 2019-03-15
Results Overview
Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
COMPLETED
PHASE1
13 participants
Baseline through study completion (Day 127)
2019-03-15
Participant Flow
Participants who discontinued from the study prior to completion were permitted to be replaced.
Participant milestones
| Measure |
1.0 mg/kg of LY3015014
LY3015014: 1.0 milligram per kilogram (mg/kg) of LY3015014 subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
|
Placebo
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
11
|
2
|
|
Overall Study
COMPLETED
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
1.0 mg/kg of LY3015014
LY3015014: 1.0 milligram per kilogram (mg/kg) of LY3015014 subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
|
Placebo
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of LY3015014 in Healthy Participants With High Cholesterol
Baseline characteristics by cohort
| Measure |
1.0 mg/kg of LY3015014
n=11 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions (Q4W) (Days 1 and 29).
|
Placebo
n=2 Participants
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Baseline Low Density Lipoprotein (LDL)-C
|
134.430 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 24.559 • n=5 Participants
|
161.060 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 1.372 • n=7 Participants
|
138.527 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 24.552 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (Day 127)Population: All enrolled participants.
Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1.0 mg/kg of LY3015014
n=11 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
n=2 Participants
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
AEs
|
3 Participants
|
1 Participants
|
|
Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 and 29: 4 hours (h) and 24 h postdosePopulation: Full analysis set (FAS): Data from all randomized participants who received at least 1 dose of the study drug according to the treatment the participants actually received and had evaluable PK data for Cmax.
The Cmax was calculated after each dose of LY3015014.
Outcome measures
| Measure |
1.0 mg/kg of LY3015014
n=11 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
After Day 1 dosing
|
5.06 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 36
|
—
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
After Day 29 dosing
|
5.57 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29: 4 h and 24 h postdosePopulation: FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for AUCt.
The AUCt was calculated after each dose of LY3015014.
Outcome measures
| Measure |
1.0 mg/kg of LY3015014
n=10 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
After Day 1 dosing
|
1960 microgram*hour per milliliter (µg*h/mL)
Geometric Coefficient of Variation 37
|
—
|
|
PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
After Day 29 dosing
|
2150 microgram*hour per milliliter (µg*h/mL)
Geometric Coefficient of Variation 46
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29: 4 h and 24 h postdosePopulation: FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for tmax.
tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.
Outcome measures
| Measure |
1.0 mg/kg of LY3015014
n=11 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
PK: Time of Maximum Concentration (Tmax) of LY3015014
After Day 1 dosing
|
4 days
Interval 4.0 to 4.0
|
—
|
|
PK: Time of Maximum Concentration (Tmax) of LY3015014
After Day 29 dosing
|
5 days
Interval 5.0 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 43 and Day 57Population: Pharmacodynamic analyses set: Participants who received at least 1 dose of investigational product according to the treatment actually received and had a baseline measurement and at least 1 post baseline measurement for LDL-C.
Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model.
Outcome measures
| Measure |
1.0 mg/kg of LY3015014
n=11 Participants
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
n=2 Participants
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Day 43
|
-49.10 µg/mL
Interval -57.34 to -40.87
|
1.38 µg/mL
Interval -17.51 to 20.27
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Day 57
|
-37.53 µg/mL
Interval -45.79 to -29.27
|
7.58 µg/mL
Interval -11.31 to 26.47
|
Adverse Events
1.0 mg/kg of LY3015014
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.0 mg/kg of LY3015014
n=11 participants at risk
LY3015014: 1.0 mg/kg of LY3015014 SQ on 2 dosing occasions Q4W (Days 1 and 29).
|
Placebo
n=2 participants at risk
Placebo: 0.9% sodium chloride injection SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
|
|---|---|---|
|
Gastrointestinal disorders
Faeces discoloured
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
General disorders
Injection site inflammation
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
Infections and infestations
Fungal skin infection
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
Investigations
Blood creatine phosphokinase increased
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • Baseline through Study Completion (Day 127)
|
50.0%
1/2 • Number of events 1 • Baseline through Study Completion (Day 127)
|
|
Renal and urinary disorders
Nephrolithiasis
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • Number of events 1 • Baseline through Study Completion (Day 127)
|
0.00%
0/2 • Baseline through Study Completion (Day 127)
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60