Esperion 1002-040 - Phase 3 Study of ETC-1002 for Hyperlipidaemia
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER LONG-TERM SAFETY AND TOLERABILITY STUDY OF ETC 1002 IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK WHO ARE NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPY
IRAS ID
194625
Contact name
Gerry (Gerrard) Rayman
Contact email
Sponsor organisation
Esperion Therapeutics, Inc.
Eudract number
2015-004136-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
Cardiovascular disease (CVD) due to atherosclerosis continues to be the leading single cause of death in industrialised countries. High serum lipid levels, and especially elevated low density lipoprotein cholesterol (LDL-C) levels, have been demonstrated to strongly and directly correlate with cardiovascular disease risks in numerous epidemiological studies. Moreover, large prospective clinical outcome trials have demonstrated that lowering LDL-C decreases cardiovascular morbidity and mortality. Despite the availability of lipid lowering therapies such as statins and ezetimibe, a significant percentage of subjects at high risk for CVD fail to reach or maintain their LDL-C treatment target.\n\nETC-1002 is a first-in-class, oral, once-daily, small molecule designed to lower LDL-C levels in patients with high cardiovascular (CV) risk due to either heterozygous familial hypercholesterolaemia (HeFH) or established atherosclerotic CVD (ASCVD) who are unable to meet their treatment goals with currently available lipid-lowering therapies.\n \nThis study is a phase 3, randomised, double-blind, placebo-controlled, parallel group, study evaluating the long-term safety and tolerability of ETC-1002 versus placebo in addition to maximally tolerated lipid-modifying therapy, including a maximally tolerated statin, in high cardiovascular risk patients with hyperlipidaemia who are not adequately treated with their current maximally tolerated lipid-modifying therapy. \n\nAfter providing consent, participants will enter a screening period approximately 2 weeks prior to Day 1 to verify their eligibility. Only participants who meet all eligibility criteria will be randomised. Participants will be randomised in a 2:1 ratio to receive either ETC-1002 180 mg (’study drug’) or placebo once daily orally over a 52 week treatment period. \n\nAs part of this study, participants will undergo physical examinations including vital signs and ECGs. Blood and urine will be taken for various lab tests. Diet and therapeutic lifestyle counselling will be provided.\n\nApproximately 900 patients will be randomised at approximately 125 sites in 6 countries.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0553
Date of REC Opinion
6 Jun 2016
REC opinion
Further Information Favourable Opinion