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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

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ETC-1002

Placebo

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

ETC-1002 120 mg (Group 1)

ETC-1002 80 mg (Group 2)

ETC-1002 40 mg (Group 3)

Placebo (Group 4)

ETC-1002 120 mg (Group 5)

ETC-1002 80 mg (Group 6)

ETC-1002 40 mg (Group 7)

Placebo (Group 8)

Arm Description

Subjects with hypercholesterolemia and normal triglycerides

Subjects with hypercholesterolemia and elevated triglycerides

Outcomes

Primary Outcome Measures

Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)

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).

Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum

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

Percent Change From Baseline to Week 12 in TG

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).

Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)

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).

Percent Change From Baseline to Week 12 in Non-HDL-C

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).

Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

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).

Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

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).

Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)

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).

Percent Change From Baseline to Week 12 in Lipoprotein (a)

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).

Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)

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).

Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)

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).

Percent Change From Baseline to Week 12 in Total LDL Particles

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).

Percent Change From Baseline to Week 12 in Total HDL Particles

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).

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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.

Number of Participants With Clinically Significant Physical Examination Findings

Clinical significance was determined by the investigator.

Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values

Clinical importance was determined by the investigator.

Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values

Clinical importance was determined by the investigator.

Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12

Laboratory abnormalities are laboratory values that are outside the normal range.

Full Information

NCT ID

NCT01262638

First Posted

December 16, 2010

Last Updated

March 15, 2021

Sponsor

Esperion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01262638

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 23, 2011 (Actual)

Study Completion Date

August 23, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Esperion Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ETC-1002 120 mg (Group 1)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and normal triglycerides

Arm Title

ETC-1002 80 mg (Group 2)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and normal triglycerides

Arm Title

ETC-1002 40 mg (Group 3)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and normal triglycerides

Arm Title

Placebo (Group 4)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and normal triglycerides

Arm Title

ETC-1002 120 mg (Group 5)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and elevated triglycerides

Arm Title

ETC-1002 80 mg (Group 6)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and elevated triglycerides

Arm Title

ETC-1002 40 mg (Group 7)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and elevated triglycerides

Arm Title

Placebo (Group 8)

Arm Type

Experimental

Arm Description

Subjects with hypercholesterolemia and elevated triglycerides

Intervention Type

Drug

Intervention Name(s)

ETC-1002

Intervention Description

ETC-1002 daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily for 12 weeks

Primary Outcome Measure Information:

Title

Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)

Description

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum

Description

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).

Time Frame

Baseline; 12 weeks

Secondary Outcome Measure Information:

Title

Percent Change From Baseline to Week 12 in TG

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Non-HDL-C

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

Description

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Lipoprotein (a)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Total LDL Particles

Description

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).

Time Frame

Baseline; 12 weeks

Title

Percent Change From Baseline to Week 12 in Total HDL Particles

Description

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).

Time Frame

Baseline; 12 weeks

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

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.

Time Frame

up to 12 weeks

Title

Number of Participants With Clinically Significant Physical Examination Findings

Description

Clinical significance was determined by the investigator.

Time Frame

up to 12 weeks

Title

Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values

Description

Clinical importance was determined by the investigator.

Time Frame

Baseline; up to 12 weeks

Title

Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values

Description

Clinical importance was determined by the investigator.

Time Frame

Baseline; up to 12 weeks

Title

Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12

Description

Laboratory abnormalities are laboratory values that are outside the normal range.

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85225

Country

United States

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60654

Country

United States

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23770179

Citation

Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.

Results Reference

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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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