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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LY3015014 intravenously (IV)

A single dose of LY3015014 up to 10.0 milligrams per kilogram (mg/kg) administered IV

Group Type EXPERIMENTAL

LY3015014 IV

Intervention Type DRUG

Administered IV over 30-90 minutes

LY3015014 IV Japanese

Single dose of LY3015014 10.0 mg/kg administered IV to Japanese participants. Added per protocol amendment effective October, 2012.

Group Type EXPERIMENTAL

LY3015014 IV

Intervention Type DRUG

Administered IV over 30-90 minutes

Placebo IV

Administered IV once only

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type DRUG

Administered IV only over 30-90 minutes

LY3015014 subcutaneously (SC)

A single dose of LY3015014 up to 3.0 mg/kg administered SC

Group Type EXPERIMENTAL

LY3015014 SC

Intervention Type DRUG

Administered SC

LY3015014 SC + Statin

A single dose of LY3015014 up to 3 mg/kg administered SC in addition to participant's dose of statin

Group Type EXPERIMENTAL

LY3015014 SC

Intervention Type DRUG

Administered SC

Placebo SC

Administered SC once only

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type DRUG

Administered SC

Interventions

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LY3015014 IV

Administered IV over 30-90 minutes

Intervention Type DRUG

Placebo IV

Administered IV only over 30-90 minutes

Intervention Type DRUG

LY3015014 SC

Administered SC

Intervention Type DRUG

Placebo SC

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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

* 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 \[including, but not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis\]

* Incidence of unexplained muscle pain, or incidence of frequent muscle cramp within the last 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes