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A Study of LY3015014 in Healthy Participants With High Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01671085
First received: August 20, 2012
Last updated: April 30, 2013
Last verified: April 2013

August 20, 2012
April 30, 2013
August 2012
March 2013   (final data collection date for primary outcome measure)
Number of participants with one or more Adverse Events (AEs) or any serious AEs [ Time Frame: Baseline through study completion (Day 127) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01671085 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Maximum concentration (Cmax) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time of maximum concentration (Tmax) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
  • Change from baseline to Day 127 in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Predose, Day 127 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY3015014 in Healthy Participants With High Cholesterol
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Healthy Volunteers
  • Hypercholesterolemia
  • Drug: LY3015014
    Administered SQ
  • Drug: Placebo
    Administered SQ
  • Experimental: 1.0 mg/kg of LY3015014
    1.0 milligrams per kilogram (mg/kg) of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
    Intervention: Drug: LY3015014
  • Placebo Comparator: Placebo
    0.9% sodium chloride injection given subcutaneously (SQ) (to match LY3015014) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
March 2013   (final data collection date for primary outcome measure)

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 LDL-Cs 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 posttreatment 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671085
14938, I5S-EW-EFJD
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP