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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01618916
First received: June 11, 2012
Last updated: February 26, 2013
Last verified: February 2013

June 11, 2012
February 26, 2013
June 2012
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01618916 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C

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.

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
  • Drug: LY3015014
    Administered SQ
  • Other: Placebo
    Administered SQ
  • 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.
    Intervention: Drug: LY3015014
  • Experimental: 1.0 mg/kg LY3015014 Every 4 Weeks
    1.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.
    Intervention: Drug: LY3015014
  • Experimental: 3.0 mg/kg LY3015014 Every 2 Weeks
    3.0 mg/kg LY3015014 given SQ once every 2 weeks for 29 days.
    Intervention: Drug: LY3015014
  • Experimental: 3.0 mg/kg LY3015014 Every 4 Weeks
    3.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.
    Intervention: Drug: LY3015014
  • Placebo Comparator: Placebo Every 2 Weeks
    Saline injection (to match LY3015014) given SQ once every 2 weeks for 29 days.
    Intervention: Other: Placebo
  • Placebo Comparator: Placebo Every 4 Weeks
    Saline injection (to match LY3015014) given SQ once every 4 weeks for 29 days.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2013
February 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, 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01618916
14354, I5S-EW-EFJB
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
February 2013

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