A study to test whether multiple doses of BI 456906 have an effect on cardiac safety in people with overweight or obesity.
This research study is testing a new medicine called BI 456906. The main goal is to find out if taking multiple doses of this medicine is safe for the heart in people who are overweight or have obesity. This is a very early stage of research, sometimes called a Phase 1 study, where we carefully check how a new medicine works in healthy volunteers for the first time. We're not testing if it treats any specific condition yet, but rather focusing on its safety. By joining, you would help scientists learn important information about this potential new medicine's effects on the body, particularly your heart.
At a glance
What is this study about?
This study is about a new medicine, or 'compound,' called BI 456906. Before any new medicine can be used to treat illnesses, doctors and scientists need to make sure it's safe. This particular study is focusing on whether giving multiple doses of BI 456906 has any effects on the heart's safety in people who are overweight or have obesity.
This is an early-stage study, often called a 'Phase 1' study. At this stage, research is carried out with healthy volunteers, not people who are ill. The main aim is to understand how the medicine behaves in the body, which doses are well-tolerated, and to carefully check for any side effects. It's a very important step to ensure potential new medicines are safe before they are tested in larger groups of people who might have certain health conditions.
By taking part, you would be contributing to vital research that helps us learn more about new medicines. The information gathered from studies like this forms the foundation for future research, which could eventually lead to new treatments that help people worldwide. Your participation helps us understand if BI 456906 is safe enough to be studied further.
Key takeaways
- This study is testing the safety of a new medicine, BI 456906, in healthy people.
- The main focus is on how the medicine affects the heart when taken multiple times.
- It's an early-stage study (Phase 1) involving healthy volunteers who are overweight or have obesity.
- Participants must be 18 years or older, both men and women are welcome.
- Taking part helps advance medical research, but there are potential risks and benefits.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for healthy people to take part. You must be at least 18 years old. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate in this research.
You should generally be in good health. This means you wouldn't have any major ongoing health problems or be taking medications that might interfere with the study medicine. Because the study focuses on safety in people who are overweight or have obesity, you would likely need to meet certain criteria related to your weight or body mass index (BMI).
The research team will carry out a thorough check-up to make sure you are suitable for the study before you can join. They will explain exactly what conditions you need to meet and answer any questions you might have about whether it's right for you.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend appointments at a study clinic regularly?
- Are you overweight or do you have obesity?
- Are you comfortable taking a new, experimental medicine?
- Are you able to understand and follow study instructions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the study medicine, BI 456906, multiple times over a certain period. This medicine would likely be given to you at the study site. You would have regular visits to the clinic for medical check-ups, which might include blood tests, urine tests, physical examinations, and special tests to monitor your heart, like an ECG (a simple test to check your heart's electrical activity). The research team would carefully monitor you throughout the study to ensure your safety and to understand how your body reacts to the medicine. There will also be follow-up visits after your last dose of the medicine to make sure you are still doing well. The total length of your participation, including all visits and follow-ups, would be explained to you by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is BI 456906?
BI 456906 is a new medicine being tested in this study. We don't know yet what it might be used for, as this study is only checking its safety.
Will this medicine help me lose weight?
This study is focused on checking the safety of the medicine, especially for your heart, not on whether it helps with weight loss. It's an early-stage study.
Is this study safe?
Patient safety is the top priority. All procedures are carefully planned, and you will be closely monitored by medical staff throughout the study.
Do I have to pay to join?
No, you do not have to pay to participate. All study-related care and medicine will be provided free of charge.
Can I leave the study at any time?
Yes, you are free to leave the study at any point, for any reason, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.