Esperion 1002-050 - Phase 3 Ext Study of ETC-1002 for Hyperlipidaemia
Research type
Research Study
Full title
A MULTICENTER OPEN-LABEL EXTENSION (OLE) STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF BEMPEDOIC ACID (ETC-1002) 180 MG
IRAS ID
223653
Contact name
Gerry (Gerrard) Rayman
Contact email
Sponsor organisation
Esperion Therapeutics, Inc.
Eudract number
2016-004115-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 10 days
Research summary
The target patient populations for this study are patients who have abnormally elevated levels of any lipids (e.g fats, triglycerides) and/or lipoproteins (principle means by which lipids are transported in the blood) in the blood (Hyperlipidemic patients) and are at high cardiovascular (CV) risk due to either an inherited genetic disorder that causes dangerously high cholesterol levels (heterozygous familial hypercholesterolemia (HeFH)) and/or established plaque build-up inside their arteries (atherosclerotic cardiovascular disease (ASCVD)) and are unable to meet their LDL C treatment goals with currently available therapies.
The study drug bempedoic acid (ETC 1002) is expected to lower LDL-C levels in patients with high cardiovascular (CV) risk, unable to meet their treatment goals with currently available lipid-lowering therapies.
This study is a phase 3, study where both the researchers and participants know which treatment is being administered to assess the long-term administration, safety and effectiveness of bempedoic acid (ETC 1002) at 180 mg.
After providing consent, participants will roll over to this study from the 1004-040 parent study that they are currently participating in. Their last visit in the parent study can be the first visit in this study. All participants will take bempoedic acid (ETC-1002) at 180 mg once daily, orally over 78 weeks.
As part of this study, participants will undergo physical examinations including vital signs. Blood and urine will be taken for various laboratory tests.
Approximately 1300 patients will be randomised at approximately 125 sites in 6 countries. Participants will have visits every 3 months. Participants will be required to visit the site at baseline (end of study [EOS] parent), Week 12, Week 52, and Week 78. Phone visits will occur at Weeks 24, 36, and 64.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0071
Date of REC Opinion
19 Apr 2017
REC opinion
Further Information Favourable Opinion