What does taking part in ORION-4 involve?
For ORION-4 to produce the best results, it is important that people stay in the study for about 5 years, if possible. Participants will need to attend the study clinic 3 times in the first 5 months and every 6 months after that. At each visit, a trained researcher (usually a nurse) will ask questions about their health, take a blood sample and give them an injection of either inclisiran or placebo.
What happens at the First appointment (Screening Visit)?
At the first study visit (called the Screening Visit), the study nurse will explain the study. Participants will have plenty of time to ask questions. If they want to continue, they will be asked to sign a Consent Form agreeing to take part.
The nurse will ask about medical history and will take a finger-prick blood sample to measure cholesterol while the participant is in the clinic. If this finger-prick cholesterol level is below a certain level, they will not be able to take part in this study.
If the participant is able to take part in ORION-4, the nurse will then give an injection into the tissue just under the skin of the tummy (abdomen). The research team will then write and inform participants' GPs to let them know that they are planning to join the study.
What happens at the Second appointment (Randomization visit)?
After about 2 months, participants will have their second appointment (called the Randomization Visit) to see if they are willing to commit to the study for about 5 years. If they are happy to continue, the nurse will take a blood sample from a vein in the arm or hand and will give the next injection.
What happens at the Other appointments (Follow-up Visits)?
The next appointment (called the Follow-up visit) will be 3 months later. After that, the study nurse will see participants every 6 months for about 5 years. At each Follow-up visit, the nurse will ask about any new medical problems since the last appointment, take a blood sample (from a vein in the arm or hand) and will give an injection.
Blood samples will be sent to the laboratory in Oxford for tests and, if participants agree, for long-term storage for future research.
Participants will not need to fast before study visits. Each Follow-up appointment will usually take less than half an hour. However, the nurse may need to keep an eye on people for up to half an hour after the injection, so at least an hour should be allowed for the visit.