A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LY3015014; Other: Placebo

• Registration Number: NCT01618916
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2018-10-17
• Results First Submitted QC: 2018-10-17
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Results First Posted: 2019-02-25
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination, including first-generation Japanese participants
• Have body mass indexes of 18 to 35 kilograms per meter square (kg/m^2), inclusive, at screening
• Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive

Exclusion Criteria

• Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
• Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
• Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
• Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3.0 mg/kg LY3015014 Every 2 Weeks	LY3015014	3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days.
1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks	LY3015014	1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days.
1.0 mg/kg LY3015014 Every 4 Weeks	LY3015014	1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
3.0 mg/kg LY3015014 Every 4 Weeks	LY3015014	3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
Placebo Every 2 Weeks	Placebo	Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days.
Placebo Every 4 Weeks	Placebo	Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014	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.
PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])	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.
Percent Change From Baseline to Days 43, 57, and 127 in LDL-C	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.
PK: Time of Maximum Concentration (Tmax) of LY3015014	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.

Trial Locations

Locations (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.; 🇺🇸 Dallas, Texas, United States