MK-0616 Cardiovascular Outcomes Study

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk

• IRAS ID

  1007842

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Major cardiovascular events (such as heart attack, stroke) are the leading cause of global death. Studies have established that high levels of (low-density lipoprotein cholesterol (LDL-C) in a person’s blood can cause major cardiovascular events. LDL-C is sometimes called “bad cholesterol.” High levels of LDL-C can cause fatty deposits (called plaque) that sticks to the walls of blood vessels and can lead to major cardiovascular events. Cholesterol is a type of fat in a person’s blood.
  MK-0616 (the trial medicine) is in a class of medicines called PCSK9i that have been shown to lower the amount of LDL-C in a person’s blood. MK-0616 is different and unique from the other medicines in this class because it is taken as a tablet by mouth and not an injection.
  The goal of the trial is to learn if MK-0616 works better than placebo on increasing the time to the first major cardiovascular event. A placebo looks like the study medicine but has no study medicine in it.
  About 14,550 people with high levels of LDL-C will be in this trial. They will be at least 18 years old and:
  • Have had a major cardiovascualr event in the past or have a high risk of having a first cardiovascular event
  • Are currently taking a statin
  • Do not have certain types of heart disease or other certain health conditions
  Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups and will receive one of these treatments as a tablet by mouth once a day:
  • Group 1- MK-0616
  • Group 2- Placebo
  Participants must fast for 8 hours before and 30 minutes after taking the treatment.
  Eligible participants may be in the trial for up to around 6 years. Neither the participants nor the researchers will know if a person gets MK-0616 or placebo (called a double-blind study).
  During the trial, participants may have blood and urine tests, tests to measure electrical activity in the heart (called ECG) and have physical examinations.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0639

• Date of REC Opinion

  26 Sep 2023

• REC opinion

  Further Information Favourable Opinion