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

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: LY3015014 Other: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline to study completion (Day 127) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics: Maximum concentration (Cmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ] [ Designated as safety issue: No ]
Pharmacokinetics: Area under the concentration curve (AUC) of LY3015014 [ Time Frame: Baseline up to Day 127 ] [ Designated as safety issue: No ]
Pharmacokinetics: Time of maximum concentration (Tmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ] [ Designated as safety issue: No ]
Change from baseline to Day 127 in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Day 127 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	June 2012
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1.0 mg/kg LY3015014 Every 2 Weeks 1.0 milligrams per kilogram (mg/kg) LY3015014 given subcutaneously (SQ) once every 2 weeks for 29 days.	Drug: LY3015014 Administered SQ
Experimental: 1.0 mg/kg LY3015014 Every 4 Weeks 1.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.	Drug: LY3015014 Administered SQ
Experimental: 3.0 mg/kg LY3015014 Every 2 Weeks 3.0 mg/kg LY3015014 given SQ once every 2 weeks for 29 days.	Drug: LY3015014 Administered SQ
Experimental: 3.0 mg/kg LY3015014 Every 4 Weeks 3.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.	Drug: LY3015014 Administered SQ
Placebo Comparator: Placebo Every 2 Weeks Saline injection (to match LY3015014) given SQ once every 2 weeks for 29 days.	Other: Placebo Administered SQ
Placebo Comparator: Placebo Every 4 Weeks Saline injection (to match LY3015014) given SQ once every 4 weeks for 29 days.	Other: Placebo Administered SQ

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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 kg/m^2, inclusive, at screening
Have screening low-density lipoprotein cholesterol (LDL-Cs) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618916

Locations

United States, Hawaii
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, 96814
United States, Texas
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, 75247

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01618916 History of Changes
Other Study ID Numbers:	14354, I5S-EW-EFJB
Study First Received:	June 11, 2012
Last Updated:	February 26, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013