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Completed

NCT Number: NCT02659397

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ETC-1002

Drug

Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)

Other names: bempedoic acid

atorvastatin

Drug

Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)

Placebo

Drug

Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)

Primary outcomes

  1. 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. 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

  3. Percent change in LDL-cholesterol

    Time frame: 4 weeks

    Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C

Secondary outcomes

  1. Percent change in hsCRP

    Time frame: 4 weeks

    Percent change from baseline to following 4 week treatment with ETC-1002

  2. Percent change in total cholesterol

    Time frame: 4 weeks

    Percent change from baseline to following 4 week treatment with ETC-1002

  3. Percent change in non-HDL-cholesterol

    Time frame: 4 weeks

    Percent change from baseline to following 4 week treatment with ETC-1002

  4. Percent change in apolipoprotein B

    Time frame: 4 weeks

    Percent change from baseline to following 4 week treatment with ETC-1002

  5. 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

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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