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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Collaborator: Medpace, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe

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