Long term treatment with inclisiran and a comparison to evolocumab

• Research type

  Research Study

• Full title

  An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-3)

• IRAS ID

  221502

• Contact name

  Danielle Curcio

• Contact email

  danielle.curcio@THEMEDCO.com

• Sponsor organisation

  The Medicines Company

• Eudract number

  2016-003815-37

• Duration of Study in the UK

  4 years, 4 months, 31 days

• Research summary

  Summary of Research
  The purpose of this study is to find out what happens to patients’ levels of ‘bad’ cholesterol when the study medicine inclisiran (formerly known as ALN-PCSSC) is given every 180 days as an injection under the skin. This will be compared with treatment with evolocumab (the comparator medicine) given every 2 weeks as an injection under the skin for approximately 1 year before switching to injections with inclisiran every 180 days for the remaining time in the study. Total study duration for each patient is approx. 4 years.

  Up to 490 patients will take part in this study at approximately 60 research centers in North America and Europe. All patients being invited to take part in the study have already completed the ORION-1 study. In the UK, about 80 patients across 14 study sites will be invited.

  Which treatment arm patients are assigned to will depend on what treatment they received in the ORION-1 study:
  • If patients received inclisiran, they will receive treatment with inclisiran for the full duration of this study (the inclisiran arm)
  • If patients received placebo, they will receive treatment with the comparator medicine evolocumab for approximately one year and then switch to inclisiran for the remaining time in the study (the comparator arm).
  
  The study will assess the safety of inclisiran and perform laboratory tests for safety and effects on blood levels (efficacy) of different types of cholesterol and other related proteins in patients’ blood including a plasma protein called PCSK9.

  In short, the purpose of the study is to:
  • Find out what effects (good and bad) inclisiran has on patients and their cholesterol levels when given for a longer time
  • Compare the effects of inclisiran with evolocumab (for those people given both medicines).
  • Find out how patients feel about the treatment with inclisiran and evolocumab.

  Summary of Results
  N/A

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  17/LO/0212

• Date of REC Opinion

  24 Feb 2017

• REC opinion

  Favourable Opinion