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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks

1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

1.0 mg/kg LY3015014 Every 4 Weeks

1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

3.0 mg/kg LY3015014 Every 2 Weeks

3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

3.0 mg/kg LY3015014 Every 4 Weeks

3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Placebo Every 2 Weeks

Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered SC

Placebo Every 4 Weeks

Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administered SC

Interventions

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LY3015014

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes