Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

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

A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients With Hypercholesterolemia Receiving Ongoing Statin Therapy

The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.

Study Type

Interventional

Enrollment (Actual)

133

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
      • Muscle Shoals, Alabama, United States, 35662
    • Arizona
      • Chandler, Arizona, United States, 85224
    • California
      • Chino, California, United States, 91710
      • Los Angeles, California, United States, 90057
      • Sacramento, California, United States, 95821
      • Walnut Creek, California, United States, 94595
    • Colorado
      • Denver, Colorado, United States, 80220
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Brandon, Florida, United States, 33511
      • Jacksonville, Florida, United States, 32216
      • Oviedo, Florida, United States, 32765
      • Ponte Vedra, Florida, United States, 32081
      • Tampa, Florida, United States, 33606
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Marietta, Georgia, United States, 30066
    • Idaho
      • Boise, Idaho, United States, 83704
      • Meridian, Idaho, United States, 83646
    • Indiana
      • Evansville, Indiana, United States, 47714
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
    • New York
      • Rochester, New York, United States, 14609
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45245
      • Columbus, Ohio, United States, 43213
      • Franklin, Ohio, United States, 45005
      • Lyndhurst, Ohio, United States, 44124
      • Marion, Ohio, United States, 43302
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
    • South Carolina
      • Greer, South Carolina, United States, 29651
      • Mount Pleasant, South Carolina, United States, 29464
      • Summerville, South Carolina, United States, 29485
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Houston, Texas, United States, 77030
    • Utah
      • Bountiful, Utah, United States, 84010
      • Orem, Utah, United States, 84058
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23294

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

Inclusion Criteria:

  • Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
  • Fasting mean TG level ≤400 mg/dL
  • Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

Exclusion Criteria:

  • Clinically significant cardiovascular disease within 12 months of screening
  • Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
  • Type 1 diabetes or uncontrolled type 2 diabetes
  • Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
  • History of chronic musculoskeletal symptoms such as fibromyalgia
  • Uncontrolled hypothyroidism
  • Liver disease or dysfunction
  • Renal dysfunction or nephritic syndrome
  • Gastrointestinal conditions or procedures or surgeries
  • Hematologic or coagulation disorders or low hemoglobin levels
  • HIV or AIDS
  • History of malignancy
  • History of drug or alcohol abuse within 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
ETC-1002 capsules, taken once daily oral
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Experimental: ETC-1002 180 mg/day
Orally, once daily in morning as capsules
Drug: ETC-1002
ETC-1002 capsules, taken once daily oral
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Placebo Comparator: Placebo
Orally, once daily in morning
Drug: Statin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Drug: Placebo
Placebo capsules, taken once daily oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)
Time Frame: 12 weeks
12 weeks
Percent change in apolipoprotein B (ApoB)
Time Frame: 12 weeks
12 weeks
Percent change in total cholesterol (TC)
Time Frame: 12 weeks
12 weeks
Percent change in high-sensitivity C-reactive protein (hsCRP)
Time Frame: 12 weeks
12 weeks
Percent change in triglycerides (TG)
Time Frame: 12 weeks
12 weeks
Percent change in lipoprotein particle number
Time Frame: 12 weeks
12 weeks
Safety using adverse event reports; clinical laboratory results
Time Frame: 12 weeks
12 weeks
Safety using adverse event reports; vital signs
Time Frame: 12 weeks
12 weeks
Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228
Time Frame: 12 weeks
12 weeks

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, 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

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

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

  • 1002-009

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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