This clinical trial is focused on studying the effects of a new treatment called MK-0616 on people who are at high risk for serious heart problems. The main condition being studied is Atherosclerotic Cardiovascular Disease (ASCVD), which is a type of heart disease caused by the buildup of fats, cholesterol, and other substances in and on the artery walls. This buildup can lead to major heart-related events, such as heart attacks or strokes.
The purpose of the study is to evaluate how well MK-0616, a film-coated tablet containing the active substance enlicitide chloride, can reduce the risk of these major heart events compared to a placebo. Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo tablet. The study will monitor participants over a period to see if the treatment helps in delaying or preventing serious heart-related events.
Throughout the study, participants will take the medication orally and will be regularly monitored by healthcare professionals. The study aims to provide valuable information on the safety and effectiveness of MK-0616 in reducing the risk of major adverse cardiovascular events in individuals with high cardiovascular risk. This research could potentially lead to new treatment options for people with heart disease.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria related to age, medical history, and current health status.
Participants must have a history of atherosclerotic cardiovascular disease (ASCVD) or be at high risk for a first major ASCVD event.
2screening visit
A screening visit is conducted to assess fasting lipid values and confirm treatment with statins or other lipid-lowering therapies.
Participants must be on a stable dose of these medications for at least 30 days prior to this visit.
3randomization
Participants are randomly assigned to receive either the study medication, MK-0616, or a placebo.
The medication is administered in the form of a film-coated tablet taken orally.
4treatment phase
During the treatment phase, participants take the assigned tablet daily.
The study aims to evaluate the effectiveness of MK-0616 in reducing major adverse cardiovascular events.
5follow-up visits
Regular follow-up visits are scheduled to monitor health status and any potential side effects.
These visits include assessments of cardiovascular health and lipid levels.
6end of study
The study is estimated to conclude by November 2029.
Final evaluations are conducted to assess the overall impact of the treatment on cardiovascular health.
Who Can Join the Study?
Must be at least 18 years old and have a history of a major event related to ASCVD (Atherosclerotic Cardiovascular Disease), such as a heart attack, stroke, or surgery to improve blood flow in the arteries, or amputation due to atherosclerosis.
If at high risk for a first major ASCVD event, must be at least 50 years old with signs of coronary artery disease, cerebrovascular disease, or peripheral artery disease, or at least 60 years old with diabetes and additional health issues like small blood vessel disease or specific urine test results, or using insulin daily, or having diabetes for at least 10 years.
Must have specific cholesterol levels measured during the screening visit: for those with a history of major ASCVD events, LDL-C (bad cholesterol) should be at least 70 mg/dL or non-HDL-C at least 100 mg/dL; for those at high risk, LDL-C should be at least 90 mg/dL or non-HDL-C at least 120 mg/dL.
Must be taking a moderate or high-intensity statin (a type of medication to lower cholesterol) with or without other lipid-lowering treatments at the screening visit.
Must have been on a stable dose of all cholesterol-lowering treatments, including statins and other medications, for at least 30 days before the screening visit, with no plans to change medications or doses during the study.
Who Cannot Join the Study?
Patients with a history of severe allergic reactions to the study medication or similar drugs.
Individuals with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication or lifestyle changes.
People with severe liver disease, which affects how the liver functions and processes substances in the body.
Participants who have had a recent heart attack or stroke, as these are serious heart and brain events.
Individuals with a history of cancer within the last five years, except for certain types of skin cancer that are not serious.
Women who are pregnant or breastfeeding, as the study medication may affect the baby.
People who are currently participating in another clinical trial, as this could interfere with the study results.
Individuals with any other medical condition that the study doctors believe would make it unsafe for them to participate.
MK-0616 is a medication being studied to see if it can help reduce the risk of major cardiovascular events, such as heart attacks or strokes, in people who are at high risk for heart disease. The trial is looking at how well this medication works in preventing these serious heart-related problems.
Atherosclerotic Cardiovascular Disease – Atherosclerotic Cardiovascular Disease (ASCVD) is a condition characterized by the buildup of fatty deposits, known as plaques, within the walls of arteries. This buildup leads to the narrowing and hardening of the arteries, which can restrict blood flow. Over time, the reduced blood flow can result in various cardiovascular complications, such as heart attacks or strokes. The disease progresses as plaques continue to accumulate, potentially leading to blockages or ruptures. This can cause significant damage to the heart and other organs due to insufficient blood supply. The progression of ASCVD is influenced by factors such as high cholesterol, high blood pressure, smoking, and diabetes.
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