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

Esperion Therapeutics, Inc.177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

177

Conditions

Dyslipidemia

Interventions

ETC-1002DRUG

ETC-1002 daily for 12 weeks

PlaceboDRUG

Placebo daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (11)

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Greenbrae, California, United States

Unnamed facility

Santa Rosa, California, United States

Unnamed facility

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

Secondary Outcomes

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).

Time frame: Baseline; 12 weeks

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).

Data from ClinicalTrials.gov

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Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Iowa City, Iowa, United States

Unnamed facility

Louisville, Kentucky, United States

Unnamed facility

Kalamazoo, Michigan, United States

Unnamed facility

Raleigh, North Carolina, United States

Unnamed facility

Houston, Texas, United States

...and 1 more locations

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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).

Time frame: Baseline; 12 weeks

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.

Time frame: up to 12 weeks

Number of Participants With Clinically Significant Physical Examination Findings

Clinical significance was determined by the investigator.

Time frame: up to 12 weeks

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

Clinical importance was determined by the investigator.

Time frame: Baseline; up to 12 weeks

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

Clinical importance was determined by the investigator.

Time frame: Baseline; up to 12 weeks

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

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

Time frame: Week 12