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

• Status: Completed
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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:

• 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