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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Esperion Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medpace, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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