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

NCT02260635 | Terminated Phase 3 Results

• 2 other identifiers: 14503I1V-JE-EIBI
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

  Baseline, Week 12

• Percent Change From Baseline in LDL-C (Direct)

  Baseline, Week 12

• Percent Change From Baseline in Non HDL-C

  Baseline, Week 12

• Percent Change From Baseline in Lipoprotein-a

  Baseline, Week 12, Week 52

• Percent Change From Baseline in Apolipoprotein A-I

  Baseline, Week 12, Week 52

Study Arms (2)

Evacetrapib

EXPERIMENTAL

130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.

Drug: Evacetrapib

Placebo

PLACEBO COMPARATOR

Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.

Drug: Evacetrapib; Drug: Placebo

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib; Placebo

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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, 530-0001, Japan

Location

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, 103-0028, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

evacetrapib

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The study was terminated prematurely due to anticipated Inefficient efficacy of the I1V-MC-EIAN (NCT01687998) study, therefore Week 52 data is not available.

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-02

Locations

JP (2)