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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01262638
First received: December 16, 2010
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: ETC-1002
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • To assess the LDL-C lowering efficacy of ETC-1002 versus placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the efficacy of ETC-1002 to modulate TG and other lipid and cardio-metabolic biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 177
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002 120 mg (Group 1)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: ETC-1002 80 mg (Group 2)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: ETC-1002 40 mg (Group 3)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: Placebo (Group 4)
Subjects with hypercholesterolemia and normal triglycerides
Drug: Placebo
ETC-1002 40 mg, 80 mg, and 120 mg versus placebo
Experimental: ETC-1002 120 mg (Group 5)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: ETC-1002 80 mg (Group 6)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: ETC-1002 40 mg (Group 7)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
Daily for 12 weeks
Experimental: Placebo (Group 8)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: Placebo
ETC-1002 40 mg, 80 mg, and 120 mg versus placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262638

Locations
United States, Arizona
Chandler, Arizona, United States, 85225
United States, California
Greenbrae, California, United States, 94904
Santa Rosa, California, United States, 95405
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Illinois
Chicago, Illinois, United States, 60654
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Michigan
Kalamazoo, Michigan, United States, 49007
United States, North Carolina
Raleigh, North Carolina, United States, 27609
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Esperion Therapeutics
  More Information

No publications provided by Esperion Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01262638     History of Changes
Other Study ID Numbers: ETC-1002-003
Study First Received: December 16, 2010
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014