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

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.

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