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Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Esperion Therapeutics Identifier:
First received: January 20, 2016
Last updated: March 14, 2017
Last verified: March 2017
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Condition Intervention Phase
Atherosclerotic Cardiovascular Diseases
Drug: ETC-1002
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy

Resource links provided by NLM:

Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by MedDRA 18.1 [ Time Frame: Baseline through 52 weeks ]

Secondary Outcome Measures:
  • Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 12, 24, and 52 weeks ]

Other Outcome Measures:
  • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in total cholesterol (TC) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in apolipoprotein B (apoB) [ Time Frame: 12, 24, and 52 weeks ]

Enrollment: 2233
Actual Study Start Date: January 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002
ETC-1002 180 mg/day
Drug: ETC-1002
ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Other Name: bempedoic acid
Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fasting LDL-C ≥ 70 mg/dL
  • High cardiovascular risk (diagnosis of HeFH or ASCVD)
  • Be on maximally tolerated lipid-modifying therapy

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50kg/m2
  • Significant cardiovascular disease or cardiovascular event in the past 3 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT02666664

  Show 98 Study Locations
Sponsors and Collaborators
Esperion Therapeutics
Study Director: Stephen Nash, MD Esperion Therapeutics
  More Information

Additional Information:
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines.. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8.

Responsible Party: Esperion Therapeutics Identifier: NCT02666664     History of Changes
Other Study ID Numbers: 1002-040
2015-004136-36 ( EudraCT Number )
Study First Received: January 20, 2016
Last Updated: March 14, 2017

Keywords provided by Esperion Therapeutics:
heterozygous familial hypercholesterolemia
atherosclerotic cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 28, 2017