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

Dyslipidemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262638
• Other study ID #: ETC-1002-003
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: August 23, 2011

Study information

• Verified date: March 2021
• Source: Esperion Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 23, 2011
• Est. primary completion date: August 23, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertriglyceridemia

Intervention

Drug:
• ETC-1002
ETC-1002 daily for 12 weeks
• Placebo
Placebo daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline; 12 weeks
Primary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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).	Baseline; 12 weeks
Secondary	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.	up to 12 weeks
Secondary	Number of Participants With Clinically Significant Physical Examination Findings	Clinical significance was determined by the investigator.	up to 12 weeks
Secondary	Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values	Clinical importance was determined by the investigator.	Baseline; up to 12 weeks
Secondary	Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values	Clinical importance was determined by the investigator.	Baseline; up to 12 weeks
Secondary	Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12	Laboratory abnormalities are laboratory values that are outside the normal range.	Week 12