Evinacumab in Patients with Persistent Hypercholesterolaemia
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
IRAS ID
244842
Contact name
Handrean Soran
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-001508-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 16 days
Research summary
Summary of Research
This is a phase 2, randomised, double-blind, placebo-controlled, dose-ranging study to assess varying doses of subcutaneous and intravenous regimens of evinacumab in patients diagnosed with primary hypercholesterolaemia(Heterozygous Familial Hypercholesterolaemia(HeFH), or non-HeFH with a history of atherosclerotic cardiovascular disease (clinical ASCVD)) who have an LDL-C ≥100 mg/dL (2.59 mmol/L), despite receiving a stable maximally tolerated statin and stable PCSK9 inhibitor antibody.REGN1500 (evinacumab), is a fully human monoclonal antibody that specifically binds to and inhibits Angiopoietin-like 3 (ANGPTL3). Preclinical and early clinical studies have demonstrated that the administration of evinacumab results in a reduction of serum Low-density lipoprotein cholesterol (LDL-C) and serum Triglycerides (TGs). Evinacumab is a new treatment option that could get patients to their target LDL-C when added to a stable lipid-lowering regimen, including statins and a PCSK9 inhibitor antibody.
In the early clinical studies in healthy patients, monotherapy treatment with evinacumab resulted in up to 40% reduction in LDL-C and up to 80% reduction in TG. It is expected that treatment with evinacumab will be well tolerated and have an acceptable safety profile. The accumulated safety information from the completed and ongoing clinical studies is marked by the absence of any important identified risks.
The study consists of 4 periods: run-in period (for patients whose background lipid modifying therapy [LMT] has not been stable prior to screening, who are not already receiving a PCSK9 inhibitor antibody, or whose background LMT has not been optimised), 2-week screening, 16-week double-blind treatment period for Subcutaneous (SC) group and 24 week double blind treatment for Intravenous (IV) group, and follow-up period that lasts 24 weeks after the last dose of study drug.
The duration of the study for a patient is approximately 41 or 46 weeks, for the SC and IV groups, respectively.
Summary of Results
Sponsor have advised that the production of Plain Language Summary is not planned for this study.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0325
Date of REC Opinion
30 Aug 2018
REC opinion
Further Information Favourable Opinion