A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: ETC-1002; Drug: Placebo

• Registration Number: NCT01751984
• Lead Sponsor: Esperion Therapeutics, Inc.

Brief Summary

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-04
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-18
• Primary Completion: 2013-05-01
• Study Completion: 2013-05-01
• Disposition First Submitted: 2015-08-13
• Disposition First Submitted QC: 2015-08-27
• Disposition First Posted: 2015-09-11
• Results First Submitted: 2022-02-10
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Results First Posted: 2022-04-04
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
• For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
• For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG <400 mg/dL

Key

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Exclusion Criteria

• Acute significant cardiovascular disease
• Poorly controlled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETC-1002	ETC-1002	ETC-1002 treatment, once daily oral
Placebo	Placebo	Placebo treatment, once daily oral

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)	Baseline; 8 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. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 8 in Apolipoprotein B	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C)	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Non-HDL-C	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Number or Participants With Treatment-emergent Adverse Events (TEAEs)	up to 8 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.
Number of Participants With Muscle-Related TEAEs	up to 8 weeks	TEAEs were defined as 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.
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C	Baseline; Weeks 2, 4, 6, and 8	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 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Total Cholesterol	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Triglycerides	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Apolipoprotein AI	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Lipoprotein (a)	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as \<3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as \<0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA)	Baseline; 8 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 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value.
Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment	Baseline; up to 8 weeks	Participants were analyzed to evaluate the LDL-C target of \<100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward).