A Study of Evacetrapib in Participants With Abnormal Cholesterol

Lilly

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02168803

15340

I1V-MC-EIBM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

Evacetrapib: Single Dose

Experimental group

Description:

Single oral dose of evacetrapib on Day 1

Treatment:

Drug: Evacetrapib

Evacetrapib: Multiple Dose 12 Weeks

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib

Evacetrapib: Multiple Dose 24 Weeks

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib

Evacetrapib: Multiple Dose 52 Weeks

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib