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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-08-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ETC-1002 120 mg (Group 1)

Subjects with hypercholesterolemia and normal triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

ETC-1002 80 mg (Group 2)

Subjects with hypercholesterolemia and normal triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

ETC-1002 40 mg (Group 3)

Subjects with hypercholesterolemia and normal triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

Placebo (Group 4)

Subjects with hypercholesterolemia and normal triglycerides

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo daily for 12 weeks

ETC-1002 120 mg (Group 5)

Subjects with hypercholesterolemia and elevated triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

ETC-1002 80 mg (Group 6)

Subjects with hypercholesterolemia and elevated triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

ETC-1002 40 mg (Group 7)

Subjects with hypercholesterolemia and elevated triglycerides

Group Type EXPERIMENTAL

ETC-1002

Intervention Type DRUG

ETC-1002 daily for 12 weeks

Placebo (Group 8)

Subjects with hypercholesterolemia and elevated triglycerides

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo daily for 12 weeks

Interventions

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ETC-1002

ETC-1002 daily for 12 weeks

Intervention Type DRUG

Placebo

Placebo daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No