Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

To evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD)

Eli Lilly and Company

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

The previous information was derived from ClinicalTrials.gov on 09/20/2013 using the identification number NCT01687998.

• Diagnosis of high risk vascular disease (HRVD) (that is, meet at least one of the disease diagnostic criteria of):
  • History of acute coronary syndrome (ACS) (that is, ≥30 days through 365 days after discharge for ACS)
  • Cerebrovascular atherosclerotic disease
  • Peripheral arterial disease
  • Diabetes mellitus with documented coronary artery disease and are clinically stable (as judged by the responsible physician).
• Must be treated with a statin for at least 30 days prior to screening. If not treated with a statin must have documented statin intolerance, or contraindication to statin
• Have a screening high-density lipoprotein cholesterol (HDL-C) ≤80 milligram per deciliter (mg/dL) (≤2.1 millimole per liter [mmol/L])
• Have screening triglycerides (TG) ≤400 mg/dL (≤4.5 mmol/L)

• Meet 1 of the following criteria:
  • Screening low-density lipoprotein cholesterol (LDL-C) no more than 10 mg/dL (0.3 mmol/L) above the target chosen by the investigator (either LDL-C <100 mg/dL [<2.6 mmol/L] or LDL-C <70 mg/dL [<1.8 mmol/L]
  • If LDL-C is greater than target, the patient participant must be on maximum tolerated statin dose (for at least 30 days), have documented statin intolerance, or contraindication to statin

• Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or :device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have previously completed or withdrawn from this study, or withdrawn from any other study investigating evacetrapib
• Female participants who are known to be pregnant or breastfeeding
• Women of child-bearing potential only, who test positive for pregnancy between screening and randomization, or who do not agree to use a reliable method of :birth control during the study
• History of transient ischemic attack (TIA) or ischemic stroke <30 days and ACS <30 days
• Any reading of systolic blood pressure ≥180 millimeter of mercury (mm Hg) or diastolic blood pressure ≥110 mm Hg at screening or randomization
• History of hemorrhagic stroke or intracranial hemorrhage
• New York Heart Association class III or IV congestive heart failure
• Serum creatinine >2.2 mg/dL (>194.5 micromole per liter [μmol/L]) at screening
• Clinically active liver disease. Participants are not excluded due to Gilbert’s Syndrome or a history of cholelithiasis/cholecystectomy
• History of malignancy within the preceding 3 years prior to screening
• Known malabsorption syndrome with the exception of lactose intolerance
• Participants with a known history of primary or secondary hyperaldosteronism
• Participants with a history of intolerance/hypersensitivity to cholesterol ester transfer protein (CETP) inhibitors
• Any clinically significant medical condition that according to the investigator could interfere with participation in the study
• Participants whose life expectancy is anticipated to be less than 4 years
• Unable or unwilling to comply with study requirements, or deemed by the investigator to be unfit for the study
• Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator
• Concurrent or anticipated need for treatment with niacin >250 mg/day or for chronic administration of drugs on the exclusion list
• Previous exposure to the CETP inhibitors dalcetrapib or evacetrapib within the last 3 months or anacetrapib within the last 12 months
• Any planned coronary angiography or coronary revascularization procedure. If angiography or revascularization is planned, participants may be screened and :enrolled after all such planned procedures are completed.

• Time to First Occurence of the Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or :Hospitalization for Unstable Angina (UA)
  • Time Frame: Baseline to study completion (estimated to be up to 4 years)
  • Designated as safety issue: No

• Mean Percent Change from Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) levels
  • Time Frame: Baseline, 3 Months
  • Designated as safety issue: No
• Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA
  • Time Frame: :Baseline through End of Study (estimated up to 4 years)
  • Designated as safety issue: No
• Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization
  • Time Frame: Baseline through End of Study (estimated up to 4 years)
  • Designated as safety issue: No
• Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA
  • Time Frame: Baseline through End of Study (estimated :up to 4 years)
  • Designated as safety issue: No
• Time to First Occurrence of Composite Endpoint of CV Death, MI, or Stroke
  • Time Frame: Baseline through End of Study (estimated up to 4 years)
  • Designated :as safety issue: No

Pending

Pending