A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: ETC-1002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01262638

ETC-1002-003

Details and patient eligibility

About

This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

Enrollment: 177 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• Provision of written informed consent prior to any study-specific procedure
• Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
• Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
• BMI between 18 and 35 mg/kg2

Major Exclusion Criteria:

• Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
• Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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177 participants in 8 patient groups

ETC-1002 120 mg (Group 1)

Experimental group

Description:

Subjects with hypercholesterolemia and normal triglycerides

Treatment:

Drug: ETC-1002

ETC-1002 80 mg (Group 2)

Experimental group

Description:

Subjects with hypercholesterolemia and normal triglycerides

Treatment:

Drug: ETC-1002

ETC-1002 40 mg (Group 3)

Experimental group

Description:

Subjects with hypercholesterolemia and normal triglycerides

Treatment:

Drug: ETC-1002

Placebo (Group 4)

Experimental group

Description:

Subjects with hypercholesterolemia and normal triglycerides

Treatment:

Drug: Placebo

ETC-1002 120 mg (Group 5)

Experimental group

Description:

Subjects with hypercholesterolemia and elevated triglycerides

Treatment:

Drug: ETC-1002

ETC-1002 80 mg (Group 6)

Experimental group

Description:

Subjects with hypercholesterolemia and elevated triglycerides

Treatment:

Drug: ETC-1002

ETC-1002 40 mg (Group 7)

Experimental group

Description:

Subjects with hypercholesterolemia and elevated triglycerides

Treatment:

Drug: ETC-1002

Placebo (Group 8)

Experimental group

Description:

Subjects with hypercholesterolemia and elevated triglycerides

Treatment:

Drug: Placebo