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A Study of LY3015014 in Healthy Participants With High Cholesterol

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ClinicalTrials.gov Identifier: NCT01671085
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Hypercholesterolemia Drug: LY3015014 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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 Subjects With Elevated LDL-C on a Stable Statin Therapy
Study Start Date : August 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).
Drug: LY3015014
Administered SQ
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).
Drug: Placebo
Administered SQ

Primary Outcome Measures :
  1. Number of participants with one or more Adverse Events (AEs) or any serious AEs [ Time Frame: Baseline through study completion (Day 127) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT01671085

United States, Florida
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.
Miramar, Florida, United States
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01671085     History of Changes
Other Study ID Numbers: 14938
I5S-EW-EFJD ( Other Identifier: Eli Lilly and Company )
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: May 1, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases