A Study of LY3015014 in Healthy Participants With High Cholesterol

Healthy Volunteers Clinical Trial

Official title:

A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Subjects With Elevated LDL-C on a Stable Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671085
• Other study ID #: 14938
• Secondary ID: I5S-EW-EFJD
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2013
• Est. primary completion date: March 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

• Have body mass indexes of 18 to 35 kilograms per square meter (kg/m^2), inclusive, at screening

• Have screening low density lipoprotein-C (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive, while having taken a stable dose of statin

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 post treatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis]

• Have significant history of or current cardiovascular (excluding controlled hypertension), 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
• Hypercholesterolemia

Intervention

Drug:
• LY3015014
Administered SQ
• Placebo
Administered SQ

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.	Miramar	Florida

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 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.	Baseline through study completion (Day 127)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014	The Cmax was calculated after each dose of LY3015014.	Day 1 and 29: 4 hours (h) and 24 h postdose
Secondary	PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014	The AUCt was calculated after each dose of LY3015014.	Day 1 and 29: 4 h and 24 h postdose
Secondary	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.	Day 1 and 29: 4 h and 24 h postdose
Secondary	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.	Baseline, Day 43 and Day 57