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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LY3015014; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01618916

14354

I5S-EW-EFJB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 6 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: LY3015014

1.0 mg/kg LY3015014 Every 4 Weeks

Experimental group

Description:

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

Treatment:

Drug: LY3015014

3.0 mg/kg LY3015014 Every 2 Weeks

Experimental group

Description:

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

Treatment:

Drug: LY3015014

3.0 mg/kg LY3015014 Every 4 Weeks

Experimental group

Description:

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

Treatment:

Drug: LY3015014

Placebo Every 2 Weeks

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Placebo Every 4 Weeks

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo