A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol (ACCENTUATE)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Atorvastatin; Drug: Ezetimibe; Drug: Placebo; Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227784

I1V-MC-EIBH (Other Identifier)

14502

Details and patient eligibility

About

The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.

Enrollment: 366 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
• Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL
• Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
• Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

Exclusion criteria

• Have a hemoglobin A1c (HbA1c) >9.5%
• New York Heart Association (NYHA) class III or IV congestive heart failure
• History of either a transient ischemic stroke or ischemic stroke <30 days
• History of acute coronary syndrome (ACS) <30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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366 participants in 4 patient groups

Atorvastatin + Evacetrapib

Experimental group

Description:

Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.

Treatment:

Drug: Evacetrapib

Drug: Placebo

Drug: Atorvastatin

Atorvastatin 80 mg

Active Comparator group

Description:

Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.

Treatment:

Drug: Placebo

Drug: Atorvastatin

Atorvastatin + Ezetimibe

Active Comparator group

Description:

Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.

Treatment:

Drug: Ezetimibe

Drug: Placebo

Drug: Atorvastatin

Atorvastatin 40 mg

Active Comparator group

Description:

Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.

Treatment:

Drug: Placebo

Drug: Atorvastatin