This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins. Following multiple doses of LY3015014, investigators will study the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body. Participants will remain in the study for about 3 months, not including screening. Screening is required within 28 days before the study starts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
13
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miramar, Florida, United States
Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
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.
Time frame: Baseline through study completion (Day 127)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
The Cmax was calculated after each dose of LY3015014.
Time frame: Day 1 and 29: 4 hours (h) and 24 h postdose
PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
The AUCt was calculated after each dose of LY3015014.
Time frame: Day 1 and 29: 4 h and 24 h postdose
PK: Time of Maximum Concentration (Tmax) of LY3015014
tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.
Time frame: Day 1 and 29: 4 h and 24 h postdose
Change From Baseline in Low Density Lipoprotein Cholesterol (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.
Time frame: Baseline, Day 43 and Day 57
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