A study to test whether BI 456906 (survodutide) influences the amount of bupropion, caffeine and midazolam in the blood in people with overweight or obesity
This research study is testing a new medicine called BI 456906. The main aim is to understand how this new medicine affects the levels of other substances in your body. We're specifically looking at how your body handles medicines like bupropion (used for depression or quitting smoking), caffeine (found in coffee and tea), and midazolam (a sedative often used before medical procedures). This is a very early-stage study, designed to understand how the medicine works in people who are overweight or have obesity. It helps us understand potential interactions if someone takes BI 456906 along with other common medicines, ensuring future treatments are as safe as possible.
At a glance
What is this study about?
This study is about a new medicine called BI 456906, which is still in the early stages of development. We want to find out if this new medicine changes how your body handles other common substances you might take. Imagine your body is like a finely tuned machine; we're checking if adding one new part (BI 456906) affects how other parts (like bupropion, caffeine, or midazolam) work and are processed.
Specifically, researchers are interested in whether BI 456906 affects the levels of bupropion (a medicine sometimes used for depression or to help stop smoking), caffeine (that stimulant in your morning cuppa!), and midazolam (a calming medicine often given before hospital procedures) in your blood. If it does, it means doctors might need to adjust doses of these other medicines if you're also taking BI 456906 in the future.
This kind of study, called a 'Phase I' study, is really important. It helps us learn about how new medicines work in the body and if there are any unexpected interactions with other substances. This information is key to making sure that any future medicines are safe and work well for patients, especially if they are already taking other medications. It's a foundational step to developing new treatments.
Key takeaways
- Tests a new medicine (BI 456906) in people who are overweight or have obesity.
- Looks at how it interacts with bupropion, caffeine, and midazolam.
- It's an early-stage study (Phase I) for safety and understanding how the body handles the medicine.
- Participation involves clinic visits and blood tests.
- Your involvement helps gather important information for future treatments.
Who may be eligible?
This study is looking for adults aged 18 years and older. Both men and women can take part. The main requirement is that you are considered overweight or have obesity.
There will be other specific things that might make you unable to join the study, even if you meet the main age and weight criteria. These typically include having certain health conditions, taking specific medications, or having allergies. Every study has rules like this to ensure the safety of participants and the accuracy of the results.
If you're interested, the study team will go through a detailed checklist with you to see if you're a good fit. They'll ask about your health history and any medicines you take to make sure it's safe for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you considered overweight or have obesity?
- Are you able to attend several clinic visits?
- Are you generally healthy, without major underlying medical conditions?
What does participation involve?
If you decide to take part, you would likely have several visits to the study clinic. These visits might involve having blood samples taken frequently to measure the levels of the medicines and substances we're interested in. You would be given the new medicine, BI 456906, and at different times, you would also receive small amounts of bupropion, caffeine, and midazolam.
The study team will carefully monitor you throughout your participation, especially after you take any of the medicines. This includes checking your vital signs like blood pressure and heart rate. You'll have regular check-ups, and the whole study period could last for several weeks or months, depending on the exact design. You will be told the total duration expected for your involvement.
Potential risks and benefits
Locations (1)
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Common questions
What is BI 456906?
It's a new medicine being tested. We're looking at how it works in the body and if it interacts with other common substances.
Why are you studying caffeine and bupropion?
Caffeine is a very common substance, and bupropion is a medication many people take. We need to know if BI 456906 affects how your body handles them.
What does 'Phase I' mean?
It's an early stage of testing a new medicine, mainly focused on how it works safely in people and how the body handles it.
Will I be given coffee or regular caffeine pills?
You will be given a measured dose of caffeine, likely in a controlled form, not regular food or drink items.
Do I have to be sick to join this study?
No, this study is for healthy volunteers who are overweight or have obesity, but not necessarily 'sick' with other conditions.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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