DyslipidemiaPhase 1NCT02168803
A Study of Evacetrapib in Participants With Abnormal Cholesterol
A Phase 1 study testing Evacetrapib in people with Dyslipidemia, run by Eli Lilly and Company at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Evacetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance
Dallas, Texas, 75247
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
Covance Clinical Research Inc
Madison, Wisconsin, 53704
About this study
Official title: 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.
- Conditions
- Dyslipidemia
- Being tested
- Evacetrapib
- Keywords
- abnormal cholesterol
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvacetrapibDrug
Also called LY2484595
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Evacetrapib: Single Dose | Experimental | Single oral dose of evacetrapib on Day 1 Receives: Drug: Evacetrapib |
| Evacetrapib: Multiple Dose 12 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks Receives: Drug: Evacetrapib |
| Evacetrapib: Multiple Dose 24 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks Receives: Drug: Evacetrapib |
| Evacetrapib: Multiple Dose 52 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks Receives: Drug: Evacetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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)
Measured: 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
Measured: 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
Measured: Day -1, Day 8
PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Measured: Day -1, Day 8
PD Parameters of Evacetrapib: Total Cholesterol Level
Measured: Day -1, Day 8
PD Parameters of Evacetrapib: Triglyceride Level
Measured: Day -1, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168803
- Sponsor's protocol ID
- 15340
- Other IDs
- I1V-MC-EIBM
- Status last verified
- Feb 2018
- First submitted
- 22 May 2014
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
- ClinicalTrials.gov ID
- NCT02168803
- Acronym / sponsor ID
- 15340
- Conditions
- Dyslipidemia
- Keywords
- abnormal cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Evacetrapib: Single Dose | Experimental | Drug: EvacetrapibSingle oral dose of evacetrapib on Day 1 |
| Evacetrapib: Multiple Dose 12 Weeks | Experimental | Drug: EvacetrapibEvacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
| Evacetrapib: Multiple Dose 24 Weeks | Experimental | Drug: EvacetrapibEvacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks |
| Evacetrapib: Multiple Dose 52 Weeks | Experimental | Drug: EvacetrapibEvacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvacetrapibAlso: LY2484595Administered orally | Drug | Evacetrapib: Multiple Dose 12 Weeks, Evacetrapib: Multiple Dose 24 Weeks, Evacetrapib: Multiple Dose 52 Weeks, Evacetrapib: Single Dose |
Primary outcome
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
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
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
4 secondary outcomes
PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
Time frame: Day -1, Day 8
PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
Time frame: Day -1, Day 8
PD Parameters of Evacetrapib: Total Cholesterol Level
Time frame: Day -1, Day 8
PD Parameters of Evacetrapib: Triglyceride Level
Time frame: Day -1, Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Evacetrapib in people with Dyslipidemia, run by Eli Lilly and Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.