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

• Status: Completed
• Trial end date: 2018-03-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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