A Study of Evacetrapib in Participants With Abnormal Cholesterol

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.

This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Evacetrapib: Single Dose

Single oral dose of evacetrapib on Day 1

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib: Multiple Dose 12 Weeks

Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib: Multiple Dose 24 Weeks

Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib: Multiple Dose 52 Weeks

Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Interventions

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Evacetrapib

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2484595

Eligibility Criteria

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Inclusion Criteria

* Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

* Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
* Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
* Hypercholesterolemia on stable statin therapy for at least 3 month
* Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria

* Have known allergies or intolerance to evacetrapib, related compounds
* Have history of recurrent rashes or chronic skin conditions
* Have significant history of or current chronic, active inflammatory conditions
* Have history or current evidence of significant neurological disorder
* Have long-standing diabetes that is insulin requiring
* Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes