A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: ETC-1002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01751984

1002-006

Details and patient eligibility

About

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
• For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
• For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG <400 mg/dL

Key Exclusion Criteria:

• Acute significant cardiovascular disease
• Poorly controlled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

ETC-1002

Experimental group

Description:

ETC-1002 treatment, once daily oral

Treatment:

Drug: ETC-1002

Placebo

Placebo Comparator group

Description:

Placebo treatment, once daily oral

Treatment:

Drug: Placebo