Odyssey FH I

• Research type

  Research Study

• Full title

  Compound: Alirocumab A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

• IRAS ID

  111744

• Contact name

  Graham Bayly

• Sponsor organisation

  sanofi-aventis Recherche & Développement

• Eudract number

  2011-005109-56

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a clinical trial of an investigatinal medicinal product called SAR236553. This clinical trial will include patients with heterozygous familial hypercholesterolaemia (heFH) and as a result have high cholesterol and are at risk of cardiovascular disease. The investigational product is a fully human monoclonal antibody, a type of protein that binds to a substance called PCSK9. This protein is secreted from the liver into the blood and reduces the removal of LDL-cholesterol from the blood and therefore higher blood circulating levels of LDL-cholesterol. Blocking PCSK9 through the use of SAR236553 can potentially decrease the blood LDL-cholesterol (bad cholesterol) levels of patients with high blood cholesterol. Although current treatment primarily with statins does lower the LDL-cholesterol, even after treatment the risk of heart disease in patient with heFH is higher, additionally only a small fraction of treated heFH patients are able to reach recommended levels of LDL-cholesterol. Thus the need for more intensive treatment is there. This specific study will therefore try and demonstrate in heFH patient 18 years of age who are not at their LDL-cholesterol goal with a maximally tolerated daily dose of statin with or without other lipid modifying therapy, that SAR236553 as add-on therapy to statins and other LMT causes a meaningful reduction in LDL-cholesterol. Participation in this study may last up to 20 months and includes about 13-14 scheduled study visits. In total it will include about 471 randomised patients across 30 research centres in western and eastern europe. The study will consist of 3 periods: A screening period of up to 2 weeks, a double-blind treatment period of 18 months and a follow-up period of 8 weeks.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0469

• Date of REC Opinion

  24 Oct 2012

• REC opinion

  Further Information Favourable Opinion