A Study of Evacetrapib in Participants With Abnormal Cholesterol

NCT02168803 | Completed Phase 1 Results

• 2 other identifiers: 15340I1V-MC-EIBM
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dyslipidemia

Keywords

abnormal cholesterol

Outcome Measures

Primary Outcomes (3)

• 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 (4)

• 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

Study Arms (4)

Evacetrapib: Single Dose

EXPERIMENTAL

Single oral dose of evacetrapib on Day 1

Drug: Evacetrapib

Evacetrapib: Multiple Dose 12 Weeks

EXPERIMENTAL

Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks

Drug: Evacetrapib

Evacetrapib: Multiple Dose 24 Weeks

EXPERIMENTAL

Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks

Drug: Evacetrapib

Evacetrapib: Multiple Dose 52 Weeks

EXPERIMENTAL

Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks

Drug: Evacetrapib

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib: Multiple Dose 12 Weeks; Evacetrapib: Multiple Dose 24 Weeks; Evacetrapib: Multiple Dose 52 Weeks; Evacetrapib: Single Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Covance

Dallas, Texas, 75247, United States

Location

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

evacetrapib

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 20, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-02

Locations

US (3)