Esperion 1002-048 (Bempedoic Acid (ETC-1002)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C
IRAS ID
223948
Contact name
Manish Saxena
Contact email
Sponsor organisation
Esperion Therapeutics Inc.
Eudract number
2016-004084-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 22 days
Research summary
This is a Phase 3, randomised, double-blind, placebo-controlled, parallel group, multicentre study that will be conducted in North America and Europe.
The main purpose of the study is to see how well the study drug (Bempedoic Acid) works to reduce the amount of low-density lipoprotein cholesterol (LDL-C) in the body in participants who have elevated (high) levels of LDL-C, have not been able to tolerate at least one statin in the past and take ezetimibe for lowering the LDL-C. The study will compare the study drug with a placebo, and will look at how the study drug may affect the level of LDL-C and certain proteins in the body and how safe the study drug is (for example, what side effects it might cause.
Approximately 225 participants at about 75 study centres in North America and Europe will take part in this study.
The participants will be assigned to one of the following study groups:
• Study drug – one 180 mg tablet once a day and ezetimibe 10 mg
• Placebo – one tablet once a day and ezetimibe 10 mg. (A placebo looks the same as the study drug but contains no actual medication).In previous studies, the study drug, bempedoic acid, worked by lowering levels of
LDL-C in the body. LDL-C is often called “bad cholesterol”. Too much LDL-C in the body can put people at risk for cardiovascular disease. Lowering levels of LDL-C may reduce the risk of complications from cardiovascular disease, such as heart attacks and stroke.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0486
Date of REC Opinion
24 Apr 2017
REC opinion
Favourable Opinion