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

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ClinicalTrials.gov Identifier: NCT01618916
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : February 27, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY3015014 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline to study completion (Day 127) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum concentration (Cmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
  2. Pharmacokinetics: Area under the concentration curve (AUC) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
  3. Pharmacokinetics: Time of maximum concentration (Tmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
  4. Change from baseline to Day 127 in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Day 127 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01618916     History of Changes
Other Study ID Numbers: 14354
I5S-EW-EFJB ( Other Identifier: Eli Lilly and Company )
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013