Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction

In brief

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Key facts

Study ID

NCT02988115

Run by

Esperion Therapeutics, Inc.

People needed

345

Starts

2016-11-16

Expected to finish

2018-03-16

Last updated by the study team

2020-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
• Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
• Be statin-intolerant (unable to tolerate 2 or more statins)

You may not qualify if…

• Total fasting triglyceride ≥500 mg/dL
• Renal dysfunction or nephrotic syndrome or history of nephritis
• Body Mass Index (BMI) ≥50 kg/m2
• Significant cardiovascular disease or cardiovascular event in the past 3 months

Where it is running

• Study site — Anaheim, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Ana, California, United States
• Study site — Torrance, California, United States
• Study site — Ventura, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Site 1 — Miami, Florida, United States
• Site 2 — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Meridian, Idaho, United States
• Study site — Evanston, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Waterloo, Iowa, United States
• Study site — Monroe, Louisiana, United States
• Study site — Slidell, Louisiana, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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