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

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Statin Therapy; Drug: ETC-1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072161

1002-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 3 patient groups, including a placebo group

ETC-1002 120 mg/day

Experimental group

Description:

Orally, once daily in morning as capsules

Treatment:

Drug: Statin Therapy

Drug: ETC-1002

ETC-1002 180 mg/day

Experimental group

Description:

Orally, once daily in morning as capsules

Treatment:

Drug: Statin Therapy

Drug: ETC-1002

Placebo

Placebo Comparator group

Description:

Orally, once daily in morning

Treatment:

Drug: Statin Therapy

Drug: Placebo