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A Study of Evacetrapib in Participants With Abnormal Cholesterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168803
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Evacetrapib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Evacetrapib: Single Dose
Single oral dose of evacetrapib on Day 1
Drug: Evacetrapib
Administered orally
Other Name: 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 Name: 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 Name: 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 Name: LY2484595




Primary Outcome Measures :
  1. 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]) [ Time Frame: 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 ]
  2. PK Parameters of Evacetrapib: Maximum Concentration (Cmax) [ Time Frame: 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 ]
  3. PK Parameters of Evacetrapib: Terminal Half-life [ Time Frame: 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 :
  1. PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level [ Time Frame: Day -1, Day 8 ]
  2. PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level [ Time Frame: Day -1, Day 8 ]
  3. PD Parameters of Evacetrapib: Total Cholesterol Level [ Time Frame: Day -1, Day 8 ]
  4. PD Parameters of Evacetrapib: Triglyceride Level [ Time Frame: Day -1, Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168803


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance
Dallas, Texas, United States, 75247
United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02168803    
Other Study ID Numbers: 15340
I1V-MC-EIBM ( Other Identifier: Eli Lilly and Company )
First Posted: June 20, 2014    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: February 2018
Keywords provided by Eli Lilly and Company:
abnormal cholesterol
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents