A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

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

A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients

The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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
    • California
      • Anaheim, California, United States, 92801
      • Los Angeles, California, United States, 90057
      • Northridge, California, United States, 91324
    • Florida
      • Clearwater, Florida, United States, 33765
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33126
      • Port Orange, Florida, United States, 32127
    • Idaho
      • Boise, Idaho, United States, 83642
    • Illinois
      • Chicago, Illinois, United States, 60607
      • Springfield, Illinois, United States, 62711
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • Carrollton, Texas, United States, 75006
    • Utah
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Arlington, Virginia, United States, 22203
      • Lynchburg, Virginia, United States, 24501
      • Richmond, Virginia, United States, 23294
    • Washington
      • Renton, Washington, United States, 98057

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Taking daily stable statin doses for at least 4 weeks prior to screening visit.
  • LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
  • LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
  • Must be willing to discontinue other lipid-regulating therapies during the study

Exclusion Criteria:

  • History of acute significant cardiovascular disease.
  • Current clinically significant cardiovascular disease.
  • History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ETC-1002 + Atorvastatin
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Drug: ETC-1002
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Other Names:
  • bempedoic acid
Drug: Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
PLACEBO_COMPARATOR: Placebo + Atorvastatin
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Drug: Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Drug: Placebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
Time Frame: 2 weeks
Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002
2 weeks
24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites
Time Frame: 2 weeks
Fold change in AUC from prior-to to following 2 week treatment with ETC-1002
2 weeks
Percent change in LDL-cholesterol
Time Frame: 4 weeks
Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in hsCRP
Time Frame: 4 weeks
Percent change from baseline to following 4 week treatment with ETC-1002
4 weeks
Percent change in total cholesterol
Time Frame: 4 weeks
Percent change from baseline to following 4 week treatment with ETC-1002
4 weeks
Percent change in non-HDL-cholesterol
Time Frame: 4 weeks
Percent change from baseline to following 4 week treatment with ETC-1002
4 weeks
Percent change in apolipoprotein B
Time Frame: 4 weeks
Percent change from baseline to following 4 week treatment with ETC-1002
4 weeks
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite
Time Frame: 2 weeks
Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002
2 weeks

Collaborators and Investigators

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

Sponsor

Esperion Therapeutics, Inc.

Investigators

  • Study Director: Mary McGowan, MD, 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

December 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (ESTIMATE)

January 20, 2016

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

  • 1002-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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