A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides

• Status: Completed
• Trial end date: 2011-08-23
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

• 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

Major Inclusion Criteria:

• Provision of written informed consent prior to any study-specific procedure

• Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements

• Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements

• BMI between 18 and 35 mg/kg2

Major Exclusion Criteria:

• Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension

• Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)