This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
51
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.
Honolulu, Hawaii, United States
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.
Dallas, Texas, United States
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
Time frame: Baseline through study completion (up to Day 127)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
The Cmax following the first dose and last dose of LY3015014 is reported.
Time frame: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])
The AUC(0-tau) following the first dose and last dose of LY3015014 is reported.
Time frame: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
PK: Time of Maximum Concentration (Tmax) of LY3015014
The tmax following the first dose and last dose of LY3015014 is reported.
Time frame: First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose
Percent Change From Baseline to Days 43, 57, and 127 in LDL-C
Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction.
Time frame: Baseline, Day 43, Day 57, and Day 127
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