Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy

Phase 2

Completed

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

• Registration Number: NCT02072161
• Lead Sponsor: Esperion Therapeutics, Inc.

Brief Summary

The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.

Detailed Description

Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Study Start: 2014-03
• Primary Completion: 2015-01
• Study Completion: 2015-01
• 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: 133

Inclusion Criteria

• Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL
• Fasting mean TG level ≤400 mg/dL
• Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)

Exclusion Criteria

• Clinically significant cardiovascular disease within 12 months of screening
• Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued
• Type 1 diabetes or uncontrolled type 2 diabetes
• Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening
• History of chronic musculoskeletal symptoms such as fibromyalgia
• Uncontrolled hypothyroidism
• Liver disease or dysfunction
• Renal dysfunction or nephritic syndrome
• Gastrointestinal conditions or procedures or surgeries
• Hematologic or coagulation disorders or low hemoglobin levels
• HIV or AIDS
• History of malignancy
• History of drug or alcohol abuse within 2 years
• Use of experimental or investigational drugs within 30 days of screening
• Use of ETC-1002 in a previous clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETC-1002 120 mg/day	ETC-1002	Orally, once daily in morning as capsules
ETC-1002 120 mg/day	Statin Therapy	Orally, once daily in morning as capsules
ETC-1002 180 mg/day	ETC-1002	Orally, once daily in morning as capsules
ETC-1002 180 mg/day	Statin Therapy	Orally, once daily in morning as capsules
Placebo	Placebo	Orally, once daily in morning
Placebo	Statin Therapy	Orally, once daily in morning

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change in total cholesterol (TC)	12 weeks
Percent change in non-high-density lipoprotein cholesterol (non-HDL-C)	12 weeks
Percent change in lipoprotein particle number	12 weeks
Percent change in apolipoprotein B (ApoB)	12 weeks
Percent change in high-sensitivity C-reactive protein (hsCRP)	12 weeks
Percent change in triglycerides (TG)	12 weeks
Safety using adverse event reports; clinical laboratory results	12 weeks
Safety using adverse event reports; vital signs	12 weeks
Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228	12 weeks