A Study of Evacetrapib in Participants With Abnormal Cholesterol

A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Evacetrapib

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evacetrapib: Single Dose; Single oral dose of evacetrapib on Day 1	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 12 Weeks; Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 24 Weeks; Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib: Multiple Dose 52 Weeks; Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks	Drug: Evacetrapib; Administered orally; Other Names: LY2484595

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: February 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: abnormal cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Evacetrapib
• Other Study ID Numbers: 15340; I1V-MC-EIBM (Other Identifier: Eli Lilly and Company)