This study involves people with cardiovascular disease, which means conditions affecting the heart and blood vessels. This includes people who have had a previous heart attack, stroke, or problems with blood flow to the legs. Some people in the study may also have type 2 diabetes, a condition where the body does not properly control blood sugar levels. The study will test a combination medication called cagrilintide semaglutide, which is given as an injection under the skin once a week. Some people will receive the active medication while others will receive placebo.
The purpose of the study is to see if this combination medication is safe for the heart and blood vessels and whether it can help prevent serious heart-related problems. The study will look at how many people experience major heart events such as heart-related death, heart attack, or stroke. The study will also look at changes in body weight, blood pressure, cholesterol levels, and blood sugar control. For people with diabetes, the study will check their HbA1c, which is a measure of average blood sugar over time.
During the study, people will receive weekly injections for up to several months. The study will collect information about any side effects and will measure various health markers through blood tests and physical examinations. The study will also assess quality of life, sleep quality, and pain levels. For people with diabetes, the study will monitor for episodes of very low blood sugar. The study will track kidney function by measuring eGFRcr, which shows how well the kidneys are filtering waste from the blood, and will check protein levels in urine. The study will continue until enough information is gathered to determine whether the medication is effective and safe.
1Treatment period with study medication
During this trial, you will receive treatment for an extended period until the study concludes, which is estimated to end in October 2027.
You will be assigned to receive either the study medication or an inactive substitute (placebo). The study medication is called CagriSema, which is a combination of two active substances: cagrilintide and semaglutide, each at a dose of 2.4 mg.
The medication will be administered as an injection under the skin (subcutaneous injection) once weekly. This means you will receive one injection every seven days throughout the treatment period.
The injection is provided as a solution that is ready to use.
2Regular monitoring visits
Throughout the trial, you will attend scheduled visits for monitoring and assessments.
During these visits, various measurements will be taken to evaluate the effects of the treatment and your overall health status.
Your body weight will be measured regularly to track any changes from the beginning of the study.
Your waist circumference and waist-to-height ratio will be measured to assess changes in body composition.
Your blood pressure will be checked, including both the upper number (systolic) and lower number (diastolic) readings.
If you have been diagnosed with type 2 diabetes before entering the study, your HbA1c level will be measured. HbA1c is a blood test that shows your average blood sugar level over the past two to three months.
Blood samples will be collected to measure various substances in your blood, including cholesterol levels (total cholesterol, HDL, LDL, VLDL), triglycerides, free fatty acids, and markers of inflammation such as hsCRP, TNF-α, IL-6, and IL-1β.
Your kidney function will be assessed by measuring eGFRcr, which estimates how well your kidneys are filtering waste from your blood. Additionally, a urine test called UACR will check for protein in your urine, which can indicate kidney health.
3Questionnaires and quality of life assessments
You will be asked to complete questionnaires at various points during the trial to assess your quality of life and well-being.
The SF-36v2 questionnaire will evaluate both your physical and mental health status.
If you experience pain, you will rate its intensity using a Numerical Rating Scale, where you assign a number to describe how much pain you feel.
Your sleep quality will be assessed using the Pittsburgh Sleep Quality Index, which asks questions about your sleep patterns and problems.
If you have nerve damage (neuropathy), your condition will be evaluated to determine whether you have painful neuropathy, painless neuropathy, or no neuropathy.
4Safety monitoring
Throughout the trial, any health problems or side effects you experience will be carefully recorded and monitored.
If you have type 2 diabetes, particular attention will be paid to episodes of severe low blood sugar (severe hypoglycemia), which occurs when your blood sugar drops to dangerously low levels requiring assistance from another person.
Any serious health events will be documented and reviewed.
The occurrence of any new cancers (malignant neoplasms) will be tracked and confirmed by a committee of medical experts.
5Cardiovascular and kidney outcome monitoring
The trial will monitor the occurrence of major cardiovascular events throughout the treatment period. These events include death due to heart or blood vessel problems, heart attack (myocardial infarction), and stroke.
Additional heart-related events will also be tracked, such as procedures to restore blood flow to the heart (coronary revascularization) and episodes of chest pain requiring hospitalization (unstable angina).
Your kidney health will be monitored for changes such as significant reduction in kidney function, development of protein in the urine (macroalbuminuria), or the need for kidney replacement therapy such as dialysis or transplantation.
The time until any of these events occur will be recorded as part of the study outcomes.
6Continuation of existing diabetes treatment
If you have type 2 diabetes and were taking diabetes medications before joining the study, you may continue taking certain medications during the trial.
Allowed medications include metformin, SGLT2 inhibitors (medications that help your kidneys remove sugar through urine), DPP4 inhibitors, alpha-glucosidase inhibitors, glinides, thiazolidinediones, sulfonylureas, or basal insulin (long-acting insulin).
You may take up to three oral diabetes medications or basal insulin combined with up to two oral medications, as prescribed by your doctor and according to local guidelines.
7Completion of the trial
The trial will continue until the planned end date, which is estimated to be in October 2027.
You will continue receiving the study treatment and attending monitoring visits until the trial concludes or until your participation ends for another reason.
Final assessments will be conducted to evaluate the overall effects of the treatment on your health.
Who Can Join the Study?
You can be male or female
You must be 55 years of age or older at the time you sign the consent form
Your body mass index (a measure of body fat based on height and weight) must be 25.0 or higher
You must have established cardiovascular disease (disease affecting the heart and blood vessels), shown by at least one of the following:
You have had a heart attack in the past (when blood flow to part of the heart is blocked)
You have had a stroke in the past (when blood flow to the brain is interrupted)
You have peripheral arterial disease with symptoms (narrowing of blood vessels in the legs), defined by at least one of these:
You experience leg pain when walking that goes away with rest, and you have an ankle-brachial index (a test comparing blood pressure in your ankle to your arm) of less than 0.85
You experience leg pain when walking that goes away with rest, and you have at least 50% narrowing in a blood vessel in your leg confirmed by imaging tests
You have had a procedure in the past to restore blood flow in a leg artery
You have had a lower leg or foot amputation due to hardening of the arteries (not caused by injury or bone infection)
If you have type 2 diabetes (a condition where your body does not use insulin properly, leading to high blood sugar), the following also applies to you:
You were diagnosed with type 2 diabetes at least 180 days (about 6 months) before joining the study
Your HbA1c level (a blood test showing your average blood sugar over the past 2-3 months) must be between 6.5% and 10%
You are managing your diabetes with one of the following:
Diet and exercise alone
Taking 1 to 3 oral diabetes medications (pills taken by mouth to control blood sugar)
Taking basal insulin (a long-acting insulin injection) alone or with up to 2 oral diabetes medications
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria (reasons why a patient cannot participate) for this clinical trial
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
The trial involves patients with cardiovascular disease, which means disease affecting the heart and blood vessels, but the specific reasons for exclusion are not included in the provided data
CagriSema is a combination medication that contains two medicines working together. It is given as an injection under the skin once a week. This medication is being tested to see if it is safe for the heart and blood vessels in people who already have heart disease.
Cagrilintide is one of the medicines in the combination. It is being studied to help with weight management and may affect how your body processes food.
Semaglutide is the other medicine in the combination. It is a medication that helps control blood sugar levels and can also help with weight loss.
Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare the effects of the actual treatment.
Cardiovascular Disease – Cardiovascular disease refers to a group of conditions that affect the heart and blood vessels. It occurs when blood vessels become narrowed or blocked, which can reduce blood flow to the heart, brain, or other parts of the body. This disease often develops over many years as fatty deposits build up on the walls of arteries, making them harder and narrower. As the condition progresses, it can lead to serious events such as heart attacks or strokes. The disease may also affect the heart muscle itself, making it harder for the heart to pump blood effectively. Risk factors include high blood pressure, high cholesterol, smoking, diabetes, obesity, and lack of physical activity.
Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart muscle is blocked. This blockage is usually caused by a blood clot that forms in a coronary artery that has been narrowed by fatty deposits. Without adequate blood supply, the affected heart muscle begins to suffer damage due to lack of oxygen. The longer the blood flow remains blocked, the greater the damage to the heart muscle. Symptoms typically include chest pain, shortness of breath, sweating, and nausea. This condition requires immediate medical attention to restore blood flow and minimize heart damage.
Stroke – A stroke happens when blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. There are two main types: ischemic stroke, caused by blocked arteries, and hemorrhagic stroke, caused by bleeding in the brain. Within minutes of being deprived of blood, brain cells begin to die. The effects of a stroke depend on which part of the brain is damaged and how much tissue is affected. Common symptoms include sudden numbness or weakness of the face, arm, or leg, confusion, trouble speaking, vision problems, and loss of balance. The severity can range from mild temporary symptoms to permanent disability.
Chronic Kidney Disease – Chronic kidney disease is a gradual loss of kidney function over time. The kidneys filter waste and excess fluids from the blood, which are then removed in urine. As the disease progresses, the kidneys become less able to perform this vital function, causing waste products and fluid to build up in the body. The condition develops in stages, from mild to complete kidney failure. In early stages, there may be no symptoms, but as kidney function declines, symptoms such as fatigue, swelling, and changes in urination may appear. Advanced stages may require dialysis or kidney transplantation to perform the work of the failing kidneys.
Angina Pectoris – Angina pectoris is chest pain or discomfort that occurs when the heart muscle does not receive enough oxygen-rich blood. It typically feels like pressure, squeezing, or tightness in the chest and may also be felt in the shoulders, arms, neck, jaw, or back. This condition is usually a symptom of underlying coronary artery disease, where the arteries supplying the heart are narrowed. Stable angina occurs predictably during physical exertion or emotional stress and improves with rest. Unstable angina is more serious, occurring unexpectedly even at rest, with symptoms that are more severe and last longer. The pain is a warning sign that the heart is working harder than usual and not getting enough oxygen.
Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects how the body processes blood sugar, also known as glucose. In this condition, the body either resists the effects of insulin or does not produce enough insulin to maintain normal glucose levels. Insulin is a hormone that helps glucose enter cells to be used for energy. Over time, high blood sugar levels can damage blood vessels and nerves throughout the body. The condition typically develops gradually, often starting with a condition called prediabetes where blood sugar levels are higher than normal but not yet high enough to be classified as diabetes. Common symptoms include increased thirst, frequent urination, increased hunger, fatigue, and blurred vision.
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