A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

Phase 2

Completed

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

• Registration Number: NCT01779453
• Lead Sponsor: Esperion Therapeutics, Inc.

Brief Summary

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Disposition First Submitted: 2015-08-13
• Disposition First Submitted QC: 2015-08-27
• Disposition First Posted: 2015-09-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
• For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion Criteria

• Acute significant cardiovascular disease
• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites	4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites	4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings	8 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change in other lipids and cardio-metabolic risk factors	2, 4, 6 and 8 weeks
Percent change in LDL-C	2, 4, 6 and 8 weeks