Do you have high LDL? If so, you may be eligible for a research study
This study is no longer recruiting. Please see currently recruiting CORALreef studies below.
About the CORALreef HeFH Study
The CORALreef HeFH study will test an oral investigational drug to see if it may safely and effectively reduce LDL-C (cholesterol) in adults aged 18 and older who have a type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH). This research study compares the investigational drug to a placebo (a placebo looks like the investigational drug but does not contain any active medicine). You will continue taking your current cholesterol 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
NATIONAL TRIAL REFERENCE NUMBER
NCT05952869
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
Recruiting CORALreef 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.
A research study testing the safety and efficacy of an investigational drug in reducing major adverse cardiovascular events in participants at high risk.
View Study PageAbout Heterozygous Familial Hypercholesterolemia—an Inherited Type of 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.1 Lowering a person’s cholesterol may help lower their chances of events such as heart attacks, stroke, and death.
Sometimes people have high cholesterol caused by a mutation (change) in their genes.2 This type of high cholesterol is passed down in families and is known as familial hypercholesterolemia.2 People with familial hypercholesterolemia are born with high cholesterol and are at risk for a heart attack at an early age.2 If you inherit high cholesterol from one parent it is called heterozygous familial hypercholesterolemia.
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.
Frequently Asked Questions
About the CORALreef HeFH study
The CORALreef HeFH 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:
- 2 in 3 (66%) chance of receiving the investigational drug
- 1 in 3 (33%) chance of receiving a placebo
You will continue to take your current cholesterol medication throughout the study. If you complete the CORALreef HeFH study, you may be eligible for a long-term extension study in which all participants receive the active investigational drug.
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 HeFH 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.
For more answers to your questions visit: https://www.merckclinicaltrials.com/faq/
Taking Part in a Research Study Is an Important Decision
If you are considering joining a research study, 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 research study 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
- About familial hypercholesterolemia. National Human Genome Research Institute. Accessed May 15, 2023. https://www.genome.gov/Genetic-Disorders/Familial-Hypercholesterolemia