LY3015014
DrugAdministered SC
NCT Number: NCT01618916
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Administered SC
Time frame: Baseline through study completion (up to Day 127)
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: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
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
The AUC(0-tau) 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
The tmax following the first dose and last dose of LY3015014 is reported.
Time frame: Baseline, Day 43, Day 57, and Day 127
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.
Eli Lilly and Company
Industry
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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