A Study of Evacetrapib in Participants With Abnormal Cholesterol

• Evacetrapib (Drug), also known as LY2484595: Administered orally

Primary outcomes

• Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]
• PK Parameters of Evacetrapib: Maximum Concentration (Cmax) [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]
• PK Parameters of Evacetrapib: Terminal Half-life [Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose]

Secondary outcomes

• PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level [Day -1, Day 8]
• PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level [Day -1, Day 8]
• PD Parameters of Evacetrapib: Total Cholesterol Level [Day -1, Day 8]
• PD Parameters of Evacetrapib: Triglyceride Level [Day -1, Day 8]

Sex: All, ages: 18 Years to any, 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

Participant flow

Outcome results

• Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) (Primary), Geometric mean, nanogram∙hour/mililliter (ng∙h/mL): Evacetrapib: Single Dose, All Participants 14200 +/- 28; Evacetrapib: Multiple Dose 12 Weeks 37400 +/- 43; Evacetrapib: Multiple Dose 24 Weeks 36900 +/- 39; Evacetrapib: Multiple Dose 52 Weeks 44400 +/- 32
• PK Parameters of Evacetrapib: Maximum Concentration (Cmax) (Primary), Geometric mean, nanogram/milliliter (ng/mL): Evacetrapib: Single Dose, All Participants 1020 +/- 32; Evacetrapib: Multiple Dose 12 Weeks 1690 +/- 41; Evacetrapib: Multiple Dose 24 Weeks 1770 +/- 39; Evacetrapib: Multiple Dose 52 Weeks 1850 +/- 28
• PK Parameters of Evacetrapib: Terminal Half-life (Primary), Number, Days: Evacetrapib: Single, Multiple Dose 12, 24, and 52 Weeks 52.5
• PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level (Secondary), Mean, millimole/Liter (mmol/L): Evacetrapib: Multiple Dose 12 Weeks 1.538 +/- 0.416; Evacetrapib: Multiple Dose 24 Weeks 1.562 +/- 0.395; Evacetrapib: Multiple Dose 52 Weeks 1.670 +/- 0.548
• PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level (Secondary), Mean, mmol/L: Evacetrapib: Multiple Dose 12 Weeks 3.711 +/- 0.958; Evacetrapib: Multiple Dose 24 Weeks 3.359 +/- 0.835; Evacetrapib: Multiple Dose 52 Weeks 3.662 +/- 1.039
• PD Parameters of Evacetrapib: Total Cholesterol Level (Secondary), Mean, mmol: Evacetrapib: Multiple Dose 12 Weeks 5.922 +/- 1.244; Evacetrapib: Multiple Dose 24 Weeks 5.523 +/- 0.736; Evacetrapib: Multiple Dose 52 Weeks 6.015 +/- 1.099
• PD Parameters of Evacetrapib: Triglyceride Level (Secondary), Mean, mmol: Evacetrapib: Multiple Dose 12 Weeks 1.474 +/- 0.849; Evacetrapib: Multiple Dose 24 Weeks 1.311 +/- 0.815; Evacetrapib: Multiple Dose 52 Weeks 1.485 +/- 0.631

Adverse events

Serious adverse events by term

Other adverse events by term

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company