Trial purpose

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularisation.

View full trial information on Clinicaltrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT06008756

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions

Arteriosclerosis, Hypercholesterolemia

Age Range

18+

Sex

All

About the trial

Current trial phase

Trial Phase 3

Length of study: The CORALreef Outcomes study lasts on average 4.5 years, up to 6 years.

Trial start and end dates
  • Trial start date October 9, 2023
  • Estimated primary completion date November 29, 2029
  • Estimated trial completion date November 29, 2029

Trial locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

NATIONAL TRIAL REFERENCE NUMBER

NCT06008756

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read this “What to Consider” page for more questions to ask and think about