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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:3/17/2019
Start Date:June 2012
End Date:February 2013

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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.


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 kilograms per meter square (kg/m^2), inclusive, at
screening

- Have screening low-density lipoprotein cholesterol (LDL-C) 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
We found this trial at
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Honolulu, HI
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Dallas, TX
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