A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02260635
• Date of registration: 06/10/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
• Scientific title: A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
• Date of first enrolment: November 2014
• Target sample size: 54
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02260635
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C
levels (measured by a direct method at baseline) that meet the following criteria.
(Participant categories are based on the definition in Japan Atherosclerosis Society
2012 guidelines.)

- Category I: 160 mg/deciliter (dL)=LDL-C<200 mg/dL

- Category II: 140 mg/dL=LDL-C<175 mg/dL

- Category III: 120 mg/dL=LDL-C<150 mg/dL

- Have triglycerides (TG) =400 mg/dL.

- Have HDL-C <100 mg/dL.

Exclusion Criteria:

- Participants on LDL apheresis or plasma apheresis.

- Participants with secondary hypercholesterolemia or familial hypercholesterolemia.

- Any planned angiography. If angiography is planned, participants may be screened and
enrolled after all such planned procedures are completed.

- History of any of the following any conditions:

- Stable angina or acute coronary syndrome (unstable angina, myocardial
infarction), old myocardial infarction or a coronary revascularization procedure
including stent placement, or symptomatic carotid artery disease

- peripheral arterial disease

- ischemic stroke or transient ischemic attack (TIA)

- intracranial hemorrhage

- abdominal aortic aneurysm

- Have systolic blood pressure (SBP) >160 millimeters of mercury (mm Hg) or diastolic
blood pressure (DBP) >100 mm Hg.

- Have a hemoglobin A1c =8.4% (National Glycohemoglobin Standardization Program).

- During the study period, participants who plan to use, are likely to require, or
unwilling or unable to stop with adequate washout any prescription, over the counter
medication, supplements or health foods with the intent to treat serum lipids (LDL-C,
HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe,
bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Participants taking probucol, fibrate or nicotinic agents within 8 weeks before
screening are excluded from the study.

- Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib
or dalcetrapib).



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: Placebo

Drug: Evacetrapib

Primary Outcome(s)

Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Percent Change From Baseline in Lipoprotein-a [Time Frame: Baseline, Week 12, Week 52]

Percent Change From Baseline in Apolipoprotein B [Time Frame: Baseline, Week 12, Week 52]

Percent Change From Baseline in LDL-C (Direct) [Time Frame: Baseline, Week 12]

Percent Change From Baseline in Non HDL-C [Time Frame: Baseline, Week 12]

Percent Change From Baseline in Apolipoprotein A-I [Time Frame: Baseline, Week 12, Week 52]

Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline, Week 12]

Secondary ID(s)

I1V-JE-EIBI

14503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02260635