This study is evaluating the safety and efficacy of an investigational drug in adults with hypercholesterolemia.
The CORALreef Lipids study will test an oral investigational drug to see if it may safely and effectively lower LDL-C (cholesterol) in adults aged 18 and older with high cholesterol. Participants must also have had, or are at risk of having, a serious health incident related to their high cholesterol, such as a heart attack, a stroke, or heart disease. This research study compares the investigational drug to a placebo (a placebo 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.
CLINICALTRIALS.GOV IDENTIFIER
NCT05952856
EU CT Number
2022-502777-42
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
Print this page with details about the study or email it to your doctor to discuss the research study during your next visit.
There are more requirements to be in this research study. The study doctor will talk with you about all the requirements for the study to see if you may qualify.
You will continue to take your current cholesterol medication, called a statin, during the research study.
Participation in the research study is voluntary, and you are free to leave the study at any time. Your privacy will be maintained throughout the study.
Length of study: Up to 1 year and 3 months, including about 8 visits to the study site and 1 phone visit
Long-term extension: If you complete the CORALreef Lipids study, you may be eligible for a long-term extension study in which all participants receive the active investigational drug
(up to 60 days)
You will have medical tests to see if you qualify for the research study. You will visit the study site 1 or more times
(52 weeks)
You will take the investigational drug or a placebo during this phase and go to the study site about 7 times
(about 8 weeks)
After you stop participating in the study, you will have 1 follow-up phone visit
Participants will be randomly placed (assigned by chance) into 1 of 2 study treatment groups. You will have a:
You will continue to take your current cholesterol medication throughout the study.
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
The CORALreef Lipids study is evaluating an oral investigational PCSK9-inhibitor (PCSK9i), called MK-0616, to see if it may help lower LDL-C (cholesterol) in adults with hypercholesterolemia who have had, or are at risk of having, an atherosclerotic cardiovascular disease (ASCVD) event.
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
The CORALreef Lipids study is being conducted to test an investigational drug in adults aged 18 years and older with high cholesterol. This research study 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. In this research study, you will be randomly placed (assigned by chance) into 1 of 2 study treatment groups. There is a:
You will continue to take your current cholesterol medication throughout the study. If you complete the CORALreef Lipids study, you may be eligible for a long-term extension study in which all participants receive the active investigational drug.
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.
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 Lipids Study is being tested for people with high cholesterol to see if it may help lower 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.
If you think this research study 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.
Print this page with details about the study or email it to your doctor to discuss the research study during your next visit.
CLINICALTRIALS.GOV IDENTIFIER
NCT05952856
EU CT Number
2022-502777-42
When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.
If you are considering joining a clinical trial, first learn as much as you can about:
Talk to your doctor about the research study before you decide to join.
References:
