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

Healthy Volunteers Clinical Trial

Official title:

A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618916
• Other study ID #: 14354
• Secondary ID: I5S-EW-EFJB
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3015014
Administered SC

Other:
• Placebo
Administered SC

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through study completion (up to Day 127)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014	The Cmax following the first dose and last dose of LY3015014 is reported.	First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
Secondary	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.	First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
Secondary	PK: Time of Maximum Concentration (Tmax) of LY3015014	The tmax following the first dose and last dose of LY3015014 is reported.	First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose
Secondary	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.	Baseline, Day 43, Day 57, and Day 127