Odyssey FH II
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid-Modifying Therapy
IRAS ID
111496
Contact name
Handrean Soran
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Eudract number
2012-001222-95
Clinicaltrials.gov Identifier
Research summary
This is a study of the investigational drug, REGN727 (study drug #157;). Participants will be selected who have high cholesterol and be at risk of cardiovascular disease. REGN727 is a fully human monoclonal antibody (a type of protein) that binds a substance called PCSK9. The substance, PCSK9, is secreted from the liver into the blood and reduces the removal of LDL-cholesterol from the blood, and therefore, higher LDL-cholesterol circulating levels. Therefore, blocking PCSK9 through the use of REGN727 can potentially decrease the blood LDL-cholesterol (bad cholesterol) levels of patients with high blood cholesterol. This study will include about 250 male and female patients aged 18 years and older at approximately 30 research centres in Western Europe and Eastern Europe. Participation in this study may last up to 20 months and includes a maximum of 13 or 14 scheduled study visits. The study consists of 3 periods: screening (up to 2 weeks), double-blind treatment (18 months) and follow up (8 weeks).
REC name
South Central - Oxford C Research Ethics Committee
REC reference
12/SC/0461
Date of REC Opinion
18 Oct 2012
REC opinion
Further Information Favourable Opinion