Esperion 1002-043 (Bempedoic Acid (ETC-1002)
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at high risk for, Cardiovascular Disease who are Statin Intolerant.
IRAS ID
217257
Contact name
Manish Saxena
Contact email
Sponsor organisation
Esperion Therapeutics Inc.
Eudract number
2016-003485-11
Duration of Study in the UK
4 years, 4 months, 30 days
Research summary
The purpose of this study is to see if the study drug (Bempedoic acid) reduces the risk of major cardiovascular (heart and blood vessel-related) events in patients with, or at high risk for, heart disease who have had complications related to taking statins. The study will compare the study drug to a placebo in reducing cardiovascular events such as heart attacks, strokes, heart-related surgeries, hospitalisations, and also death occurring for patients in the study. The study will also look at how the study drug may affect the level of cholesterol and certain proteins in the body and how safe the study drug is (for example, what side effects it might cause).
Approximately 12,600 patients at about 1000 study centres in up to 30 countries will take part in this study. The participants will be assigned to one of the following groups:• Study drug – one 180 mg tablet once a day
• Placebo – one tablet once a day.(A placebo looks the same as the study drug but contains no actual medication)Bempedoic acid has been evaluated in 19 completed clinical studies, with over 2300 subjects and patients who received at least 1 dose of study medication, with more than 1500 of these receiving bempedoic acid doses ranging from 2.5 up to 240 mg/day. The 2300 number includes more than 800 patients in the Phase 3 safety population from
an on going double-blind study. All multiple-dose studies have demonstrated consistent, clinically meaningful LDL-C lowering with bempedoic acid treatment and have shown a positive safety profile.REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0438
Date of REC Opinion
30 May 2017
REC opinion
Further Information Favourable Opinion