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

Summary

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.

Timeline

Start

2014-10

Primary completion

2015-12

Completion

2015-12

Outcome

Met primary endpoint

Stopped: “Study termination due to program termination.”

registry analysis (unspecified test); Atorvastatin + Evacetrapib vs Atorvastatin 40 mg; p <0.001; Median Difference (Final Values) -33.48 (95% CI -44.4 to -23.3); ANCOVA NCT02227784 ↗

registry analysis (unspecified test); Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe; p = 0.045; Median Difference (Final Values) -6.14 (95% CI -12.2 to -0.22); ANCOVA NCT02227784 ↗

paper Addition of evacetrapib significantly reduced LDL-C (-33%) compared with ezetimibe (-27%, p=0.045), increasing statin dose (-6%) and statin alone (0%, p<0.001). PMID 28412650 ↗

Publications

• Nicholls SJ, Ray KK, Ballantyne CM, Beacham LA, Miller DL, Ruotolo G, Nissen SE, Riesmeyer JS; ACCENTUATE Investigators. Comparative effects of cholesteryl ester transfer protein inhibition, statin or ezetimibe on lipid factors: The ACCENTUATE trial. Atherosclerosis. 2017 Jun;261:12-18. doi: 10.1016/j.atherosclerosis.2017.04.008. Epub 2017 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	40 mg	Oral
Subject	Atorvastatin	Small molecule	80 mg	Oral
Subject	Evacetrapib	Small molecule	130 mg	Oral
Comparator	Ezetimibe	Unknown	10 mg	Oral

Indications