Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: ETC-1002; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01941836

1002-008

Details and patient eligibility

About

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Full description

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Enrollment: 349 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Statin intolerant and statin tolerant
• Fasting LDL-C between 130 mg/dL and 220 mg/dL
• Fasting triglyceride less than or equal to 400 mg/dL
• Body mass index (BMI) between 18 and 45 kg/m2

Key Exclusion Criteria:

• History or current clinically significant cardiovascular disease
• History or current type 1 diabetes or uncontrolled type 2 diabetes
• Use of metformin or thiazolidinediones (TZD) within 3 months of screening
• History of joint symptoms difficult to differentiate from myalgia
• Uncontrolled hypothyroidism
• Liver disease or dysfunction
• Renal dysfunction or nephritic syndrome
• Gastrointestinal (GI) conditions or prior GI procedures
• HIV or AIDS
• History or malignancy
• History or drug or alcohol abuse within last 2 years
• Use of experimental or investigational drugs within 30 days of screening
• Use of ETC-1002 in a previous clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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349 participants in 5 patient groups

ETC-1002 120 mg/day

Experimental group

Description:

Orally, once daily in morning as capsules

Treatment:

Drug: ETC-1002

ETC-1002 180 mg/day

Experimental group

Description:

Orally, once daily in morning as capsules

Treatment:

Drug: ETC-1002

ezetimibe 10mg/day

Active Comparator group

Description:

Orally, once daily in morning as capsules

Treatment:

Drug: Ezetimibe

ETC-1002 120 mg/day + ezetimibe 10mg/day

Experimental group

Description:

Orally, once daily in morning

Treatment:

Drug: ETC-1002

Drug: Ezetimibe

ETC-1002 180 mg/day + ezetimibe 10mg/day

Experimental group

Description:

Orally, once daily in morning

Treatment:

Drug: ETC-1002

Drug: Ezetimibe