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

Hypercholesterolemia Clinical Trial

Official title:

A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02260635
• Other study ID #: 14503
• Secondary ID: I1V-JE-EIBI
• Status: Terminated
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind treatment period will last for 12 weeks and the open-label extension period will last for an additional 40 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Evacetrapib
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka
Japan	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification	Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline in LDL-C (Direct)	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline in Non HDL-C	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.	Baseline, Week 12
Secondary	Percent Change From Baseline in Lipoprotein-a	LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.	Baseline, Week 12, Week 52
Secondary	Percent Change From Baseline in Apolipoprotein A-I	LS Mean from ANCOVA model adjusted for baseline and treatment.	Baseline, Week 12, Week 52
Secondary	Percent Change From Baseline in Apolipoprotein B	LS Mean from ANCOVA model adjusted for baseline and treatment.	Baseline, Week 12, Week 52