A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01426412
First received: August 29, 2011
Last updated: August 15, 2013
Last verified: August 2013

August 29, 2011
August 15, 2013
September 2011
June 2013   (final data collection date for primary outcome measure)
Number of participants with clinically significant effects (vital signs, Electrocardiogram (ECG), infusion reaction, immunogenicity, and labs) [ Time Frame: Baseline to study completion (up to 22 weeks) ] [ Designated as safety issue: Yes ]
Number of participants with clinically significant effects (vital signs, Electrocardiogram (ECG), infusion reaction, immunogenicity, and labs) [ Time Frame: Baseline to study completion (estimate 7 months) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01426412 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: area under the concentration-time curve (AUC) of LY3015014 [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum concentration (Cmax) of LY3015014 [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]
  • Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the concentration-time curve (AUC) of LY3015014 [ Time Frame: Pre-dose up to Day 85 post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum concentration (Cmax) of LY3015014 [ Time Frame: Pre-dose up to Day 85 post-dose ] [ Designated as safety issue: No ]
  • Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Pre-dose up to Day 85 post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Subjects With Elevated LDL-C

This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low density lipoprotein cholesterol (LDL-C). Following single 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 remain in the study for approximately up to 6 months.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: LY3015014 (intravenously)
    Administered intravenously over 30-90 minutes
  • Drug: Placebo (intravenously)
    Administered intravenously only over 30-90 minutes
  • Drug: LY3015014 (subcutaneously)
    Administered subcutaneously
  • Drug: Placebo (subcutaneously)
    Administered subcutaneously
  • Experimental: LY3015014 IV
    A single dose of LY3015014 up to 10.0 mg/kg administered intravenously
    Intervention: Drug: LY3015014 (intravenously)
  • Experimental: LY3015014 IV Japanese
    Single dose of LY3015014 10.0 mg/kg administered intravenously to Japanese participants. Added per protocol amendment effective October, 2012.
    Intervention: Drug: LY3015014 (intravenously)
  • Placebo Comparator: Placebo IV
    Administered intravenously once only
    Intervention: Drug: Placebo (intravenously)
  • Experimental: LY3015014 SC
    A single dose of LY3015014 up to 3.0 mg/kg administered subcutaneously
    Intervention: Drug: LY3015014 (subcutaneously)
  • Experimental: LY3015014 SC + Statin
    A single dose of LY3015014 up to 3 mg/kg administered subcutaneously in addition to participant's dose of statin
    Intervention: Drug: LY3015014 (subcutaneously)
  • Placebo Comparator: Placebo SC
    Administered subcutaneously once only
    Intervention: Drug: Placebo (subcutaneously)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • To qualify as Japanese for the purpose of this study, the participant must be first-generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan. Japanese participants have to be between the ages of 20-65, inclusive, at screening
  • Statin naive participants, have a screening LDL-C of between 100 and 180 milligrams per deciliter (mg/dL), inclusive; for participants currently taking a statin, have a screening LDL-C of between 100 and 160 mg/dL
  • Have serum triglycerides <400 mg/dL

Additional inclusion criteria for participants in the statin-interaction cohort:

  • At screening, must have been on a stable dose of either atorvastatin (10 to 40 mg once daily [QD]), rosuvastatin (5 to 20 mg QD), simvastatin (20 to 40 mg QD), lovastatin (40 to 80 mg QD), or pravastatin (40 to 80 mg QD) which has been well tolerated for at least 3 months

Exclusion Criteria:

  • Have known allergies to compounds related to LY3015014 or any components of the formulation, or known clinically significant hypersensitivity to biologic agents, or known allergies to acetaminophen and/or antihistamines
  • Intend to use over-the-counter or prescription medication within 14 days prior to dosing (excluding the statins listed in Inclusion Criterion other than estrogen/progesterone as hormone replacement therapy (HRT) and thyroid medications. Participants taking these medications should be on chronic, stable doses. Certain medications, for example vitamin supplements, may be permitted at the discretion of the investigator and the sponsor. Participants on statins may be allowed to be on a stable dose of single hypertensive agent if agreed upon by sponsor and investigator
  • Have received any vaccine(s) within 1 month of LY3015014 dosing, or intend to 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
  • Have a history of atopy, or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

Additional exclusion criteria for participants in the statin-interaction cohort:

  • Incidence of unexplained muscle pain, or incidence of frequent muscle cramp within the last 6 months
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01426412
13980, I5S-EW-EFJA
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
August 2013

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