CompletedPhase 2

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

United States349 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change in calculated low density lipoprotein-cholesterol (LDL-C)

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT01941836

SponsorEsperion Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Hypercholesterolemia trials