Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

March 26, 2019 updated by: Esperion Therapeutics, Inc.

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Muscle Shoals, Alabama, United States, 35662
    • Arizona
      • Chandler, Arizona, United States, 85224
    • California
      • Beverly Hills, California, United States, 90211
      • Chino, California, United States, 91710
      • Lincoln, California, United States, 95821
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90059
      • Newport Beach, California, United States, 92663
      • Thousand Oaks, California, United States, 91360
      • Vista, California, United States, 92083
    • Colorado
      • Denver, Colorado, United States, 80220
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Atlantis, Florida, United States, 33462
      • Brandon, Florida, United States, 33511
      • Hialeah, Florida, United States, 33012
      • Jacksonville, Florida, United States, 32223
      • Oviedo, Florida, United States, 32765
      • Ponte Vedra, Florida, United States, 32081
      • Port Orange, Florida, United States, 32127
      • Saint Petersburg, Florida, United States, 33756
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Decatur, Georgia, United States, 30033
      • Marietta, Georgia, United States, 30066
    • Idaho
      • Meridian, Idaho, United States, 83646
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Kansas City, Kansas, United States, 66214
    • Maine
      • Auburn, Maine, United States, 04210
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • New Jersey
      • Clifton, New Jersey, United States, 07012
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • New Windsor, New York, United States, 12553
      • Rochester, New York, United States, 14609
      • Williamsville, New York, United States, 14221
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
      • Raleigh, North Carolina, United States, 27609
      • Salisbury, North Carolina, United States, 28144
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Beachwood, Ohio, United States, 26900
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45227
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43213
      • Franklin, Ohio, United States, 45005
      • Lyndhurst, Ohio, United States, 44124
      • Marion, Ohio, United States, 43302
      • Willoughby Hills, Ohio, United States, 44094
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74136
    • Oregon
      • Eugene, Oregon, United States, 97404
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Austin, Texas, United States, 78731
      • Dallas, Texas, United States, 75216
      • Dallas, Texas, United States, 75230
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77072
      • Round Rock, Texas, United States, 78681
    • Utah
      • Orem, Utah, United States, 84058
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23294
    • Washington
      • Olympia, Washington, United States, 98502
      • Renton, Washington, United States, 98057
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Statin intolerant and statin tolerant
  • Fasting LDL-C between 130 mg/dL and 220 mg/dL
  • Fasting triglyceride less than or equal to 400 mg/dL
  • Body mass index (BMI) between 18 and 45 kg/m2

Key Exclusion Criteria:

  • History or current clinically significant cardiovascular disease
  • History or current type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 3 months of screening
  • History of joint symptoms difficult to differentiate from myalgia
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal (GI) conditions or prior GI procedures
  • HIV or AIDS
  • History or malignancy
  • History or drug or alcohol abuse within last 2 years
  • Use of experimental or investigational drugs within 30 days of screening
  • Use of ETC-1002 in a previous clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETC-1002 120 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
Patients receive ETC-1002
Experimental: ETC-1002 180 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
Patients receive ETC-1002
Active Comparator: ezetimibe 10mg/day
Orally, once daily in morning as capsules
Drug: Ezetimibe
Patients receive ezetimibe
Other Names:
  • Zetia
Experimental: ETC-1002 120 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
Drug: ETC-1002
Patients receive ETC-1002
Drug: Ezetimibe
Patients receive ezetimibe
Other Names:
  • Zetia
Experimental: ETC-1002 180 mg/day + ezetimibe 10mg/day
Orally, once daily in morning
Drug: ETC-1002
Patients receive ETC-1002
Drug: Ezetimibe
Patients receive ezetimibe
Other Names:
  • Zetia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in calculated low density lipoprotein-cholesterol (LDL-C)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Safety using adverse event reports; vital signs
Time Frame: up to 21 weeks including screening
up to 21 weeks including screening
Percent change in Apolipoprotein B (ApoB)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Percent change in high sensitivity C-reactive protein (hsCRP)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Safety using adverse event reports; clinical laboratory results
Time Frame: up to 21 weeks including screening
up to 21 weeks including screening
Safety using adverse event reports; rates of muscle-related adverse
Time Frame: up to 21 weeks including screening
up to 21 weeks including screening

Other Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic plasma trough concentrations of ETC-1002 and its metabolite ESP15228
Time Frame: Week 2, Week 4, Week 8 and Week 12
Week 2, Week 4, Week 8 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esperion Therapeutics, Inc.

Collaborators

Medpace, Inc.

Investigators

  • Study Director: Diane E MacDougall, MS, Esperion Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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