A Study of the Efficacy and Safety of ETC-1002 in Subjects With Statin Intolerance

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the LDL-C lowering efficacy and safety of ETC-1002 versus placebo in subjects with hypercholesterolemia and a history of statin intolerance.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment

• For subjects on current lipid-regulating drugs - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)

• For subjects not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG <400 mg/dL

Key Exclusion Criteria:

• Acute significant cardiovascular disease

• Poorly controlled hypertension