Do you have high LDL? If so, you may be eligible for a research study
See if you may qualify for a cholesterol research study.
About These Research Studies
The CORALreef Clinical Trial program includes studies that are testing whether an oral investigational drug may safely and effectively lower LDL-C (cholesterol) levels.
The research studies will compare the investigational drug to a placebo (an inactive substance that looks like the investigational drug but does not contain any active medicine). If you currently take a cholesterol medication, you must continue that medication during the research study. The investigational drug is a tablet taken by mouth once a day.
Researchers want to:
- Learn about the safety of the oral investigational drug and any side effects
- Evaluate whether the investigational drug may reduce cholesterol levels
Discuss With Your Doctor or Research Team
Print this page with details about the study or email it to your doctor to discuss the research study during your next visit.
How to Qualify:
You may be able to take part in one of these research studies if you are at least 18 years old and have high cholesterol. Read about the different studies below.
There are more requirements to participate in these research studies. The study doctor will talk with you about all the requirements for the study that is the best fit for you.
If you qualify for one of these studies and decide to participate:
- You may receive the oral investigational drug and all study-related medical tests at no cost
- Your overall health will be monitored by a study doctor
- You may help researchers learn more about high cholesterol and the oral investigational drug
Participation in any of these research studies is voluntary, and you are free to leave the study at any time. Your privacy will be maintained throughout the study.
Learn About the Different Studies
We are evaluating the safety and efficacy of an investigational medicine in multiple studies simultaneously. Below are different studies with differing qualifications. Explore each study and speak with your doctor to determine if you may qualify for one.
About High Cholesterol
Cholesterol is a type of fat in a person’s blood. LDL-C is sometimes called the “bad cholesterol” and having too much can cause cholesterol or fatty deposits to stick to the walls of arteries (called plaque). This causes the arteries to narrow, which means less blood can flow through them. Lowering a person’s cholesterol may help lower their chances of events such as heart attacks, stroke, and death.
Since high cholesterol has no symptoms, it is important to monitor and treat it as needed to avoid more serious health complications.1
For Healthcare Professionals
The CORALreef studies are evaluating an oral investigational PCSK9-inhibitor (PCSK9i), called MK-0616, to see if it may help lower LDL-C (cholesterol) levels.
Studies currently being conducted with MK-0616 include:
MK-0616-015
Long-term cardiovascular events study in adults who have a history of ASCVD or are at high risk for developing ASCVD and are taking a statin
Participants will continue their current lipid-lowering standard of care/optimized treatment regimen during the studies.
Frequently Asked Questions
About the CORALreef Studies
The CORALreef studies are being conducted to test an investigational drug in adults aged 18 and older who have high cholesterol. These research studies will evaluate whether the oral investigational drug may safely and effectively lower cholesterol levels.
Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the research study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo looks like the investigational drug but does not contain any active medicine. Some of the research studies will have a placebo and some will not. The study doctor will give you more information depending on which research study is the best fit for you. If you currently take a cholesterol medication called a statin, you will continue that medication during the study.
Privacy, Withdrawing, Costs, and Permission
The study team respects and protects your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Your participation in the research study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused drug.
No. You will receive the study treatment at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
About Research Studies
A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medication is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.
Before a research study can begin, a review board or ethics committee must review the study. In the U.S., this group is called an IRB or institutional review board. An IRB is made up of doctors, scientists, and members of the community.
Only people who meet all eligibility criteria for a research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational drug is a drug that hasn’t yet been approved for use in the general public. In order to be approved, the investigational drug must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational drug in the CORALreef studies is being tested in people with high cholesterol to see if it may help lower their cholesterol levels.
If available in your location and you meet requirements, you may be offered the opportunity to join another trial known as a “long-term extension study” in which all participants receive the active investigational drug.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions visit: https://www.msdclinicaltrials.com/faq/
What Can You Do Next?
If you think one of these research studies might be a good fit and you are interested in taking part, take the next step to see if you are eligible. The study doctor will help determine which research study is the best fit for you.
Discuss With Your Doctor or Research Team
Print this page with details about the study or email it to your doctor to discuss the research study during your next visit.
Taking Part in a Research Study 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 possible risks and benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about
References:
- What is high cholesterol? Heart UK. Accessed May 11, 2023. https://www.heartuk.org.uk/cholesterol/what-is-high-cholesterol