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

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ClinicalTrials.gov Identifier: NCT01262638
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : March 16, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: ETC-1002 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2010
Actual Primary Completion Date : August 23, 2011
Actual Study Completion Date : August 23, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ETC-1002 120 mg (Group 1)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: ETC-1002 80 mg (Group 2)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: ETC-1002 40 mg (Group 3)
Subjects with hypercholesterolemia and normal triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: Placebo (Group 4)
Subjects with hypercholesterolemia and normal triglycerides
Drug: Placebo
Placebo daily for 12 weeks

Experimental: ETC-1002 120 mg (Group 5)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: ETC-1002 80 mg (Group 6)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: ETC-1002 40 mg (Group 7)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: ETC-1002
ETC-1002 daily for 12 weeks

Experimental: Placebo (Group 8)
Subjects with hypercholesterolemia and elevated triglycerides
Drug: Placebo
Placebo daily for 12 weeks




Primary Outcome Measures :
  1. Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward).

  2. Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).


Secondary Outcome Measures :
  1. Percent Change From Baseline to Week 12 in TG [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TG values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  2. Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  3. Percent Change From Baseline to Week 12 in Non-HDL-C [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing non-HDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  4. Percent Change From Baseline to Week 12 in Total Cholesterol (TC) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing TC values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  5. Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoB values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  6. Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing ApoAI values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  7. Percent Change From Baseline to Week 12 in Lipoprotein (a) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing Lipoprotein (a) values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  8. Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing FFA values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  9. Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the value from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing hsCRP values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  10. Percent Change From Baseline to Week 12 in Total LDL Particles [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  11. Percent Change From Baseline to Week 12 in Total HDL Particles [ Time Frame: Baseline; 12 weeks ]
    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and TG stratum and Baseline value as a covariate. Missing values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

  12. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: up to 12 weeks ]
    TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.

  13. Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: up to 12 weeks ]
    Clinical significance was determined by the investigator.

  14. Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values [ Time Frame: Baseline; up to 12 weeks ]
    Clinical importance was determined by the investigator.

  15. Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values [ Time Frame: Baseline; up to 12 weeks ]
    Clinical importance was determined by the investigator.

  16. Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12 [ Time Frame: Week 12 ]
    Laboratory abnormalities are laboratory values that are outside the normal range.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262638


Locations
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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, Inc.
Publications of Results:
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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01262638    
Other Study ID Numbers: ETC-1002-003
First Posted: December 17, 2010    Key Record Dates
Results First Posted: March 16, 2021
Last Update Posted: March 17, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Dyslipidemias
Hypertriglyceridemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs