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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Collaborator: Medpace, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

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