This clinical trial is focused on studying the effects of a treatment called BI 456906 on people who are overweight or have obesity. The study is particularly interested in individuals who have existing heart conditions, known as cardiovascular disease (CVD), or chronic kidney disease, and those who have at least two other health issues related to their weight that could increase their risk of heart problems. The treatment, BI 456906, is given as a solution for injection under the skin, a method known as subcutaneous use.
The purpose of the study is to evaluate the safety of BI 456906 in terms of heart health compared to a placebo. Participants will receive either the treatment or a placebo and will be monitored over time to see if there are any differences in the occurrence of heart-related events such as heart attacks, strokes, or heart failure. The study will also look at changes in body weight, blood pressure, and other health markers over a period of time.
Participants in the study will be followed for several weeks, with regular check-ups to monitor their health and any changes that occur. The study aims to provide valuable information on whether BI 456906 is a safe and effective treatment option for people with obesity and related health conditions. The results could help improve the management of obesity and its complications in the future.
1joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication, BI 456906, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.
2medication administration
The medication, BI 456906, is administered as a solution for injection. It is given through a method called subcutaneous use, which means it is injected under the skin.
The frequency and dosage of the medication will be determined by the study protocol, and you will be informed about the specific schedule you need to follow.
3monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the medication. This may include physical examinations, blood tests, and other assessments as required by the study protocol.
You will be asked to attend scheduled visits to the study site for these assessments. The study team will provide you with a detailed schedule of these visits.
4study duration
The study is expected to last until April 2026. During this time, you will continue to receive the study medication or placebo and attend regular follow-up visits.
Your participation is crucial for the entire duration of the study to ensure the collection of comprehensive data regarding the medication’s effects.
5end of study
At the end of the study, a final assessment will be conducted to evaluate your health and any changes that may have occurred during the study period.
The results of the study will be analyzed to determine the safety and effectiveness of BI 456906 in individuals with overweight or obesity and cardiovascular conditions.
Who Can Join the Study?
Must be a male or female who is at least 18 years old at the time of signing the consent form. In some countries, you must be older if the legal age of consent is more than 18 years.
Must have a Body Mass Index (BMI) of 27 kg/m2 or higher at the screening. BMI is a measure that uses your height and weight to work out if your weight is healthy.
If your BMI is between 27 and 30 kg/m2, you must have either established Cardiovascular Disease (CVD) or at least two weight-related complications or risk factors for CVD, or a combination of both. CVD refers to conditions affecting the heart and blood vessels.
If your BMI is 30 kg/m2 or higher, you must have either established CVD or Chronic Kidney Disease (CKD), or at least two weight-related complications or risk factors for CVD, or any combination of these. CKD is a long-term condition where the kidneys do not work as well as they should.
Additional criteria may apply.
Who Cannot Join the Study?
Patients with a history of heart attack (also known as myocardial infarction) cannot participate.
Patients who have experienced a stroke (a condition where blood flow to the brain is interrupted) are excluded.
Individuals who have undergone coronary revascularization (a procedure to restore blood flow to the heart) due to ischemia (reduced blood flow) are not eligible.
Those with a history of heart failure (a condition where the heart does not pump blood as well as it should) cannot join the study.
Patients who have experienced cardiovascular death (death related to heart or blood vessel problems) are not eligible.
Survodutide is a medication being tested in this clinical trial. It is given as an injection under the skin. The main goal of using survodutide in this study is to see if it is safe for people who are overweight or have obesity, especially those who also have heart disease or kidney problems. The researchers want to find out if survodutide can help reduce the risk of serious heart-related events like heart attacks, strokes, or heart failure. They are comparing survodutide to a placebo to see if it works better or at least as well in preventing these health issues.
Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in weight gain. Obesity progresses gradually and can lead to increased body mass index (BMI), which is a measure of body fat based on height and weight. As obesity advances, it can contribute to the development of other health issues, such as cardiovascular diseases and type 2 diabetes. The condition can also affect physical mobility and overall quality of life.
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