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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT02072161

Run by

Esperion Therapeutics, Inc.

People needed

133

Starts

2014-03-01

Expected to finish

2015-01-01

Last updated by the study team

2019-03-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Chino, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Brandon, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — Ponte Vedra, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Evansville, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Port Gibson, Mississippi, United States
• Study site — Rochester, New York, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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