A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure
This research study is investigating a new medicine, XXB750, for individuals living with heart failure. We want to understand how effective XXB750 is at improving your condition, what the most suitable dose might be, and if it's safe to use. To do this, we'll be comparing XXB750 against a 'dummy' treatment (placebo) and other established heart failure medications. The study will last for 24 weeks and will primarily look at changes in a blood test marker called NT-proBNP, which helps us understand how your heart is doing. We'll also be carefully checking for any side effects and monitoring your general health throughout the study.
At a glance
What is this study about?
Heart failure is a serious condition where your heart can't pump enough blood around your body. This can make you feel tired, breathless, and cause swelling in your legs. While there are already medicines to help manage heart failure, doctors are always looking for new and better ways to treat it. This study is testing a new medicine called XXB750.
This study, often called a 'Phase II' trial, is an important step in developing new medicines. It's a bit like a trial run to see if the new medicine, XXB750, shows promise in helping people with heart failure. We want to figure out the right amount of the medicine to give (the dose) and check if it's safe and well-tolerated. We also want to see how it compares to a dummy medicine (placebo) and some of the treatments people already take for heart failure.
The main thing we'll be looking at is a blood test marker called NT-proBNP. Changes in this marker can tell us how your heart is responding to the treatment. We'll measure this at the beginning of the study and again after 16 weeks. We'll also be keeping a close eye on any side effects you might experience and generally checking your health to make sure the medicine is safe for you.
Key takeaways
- This study is for people with heart failure.
- It's testing a new medicine called XXB750.
- The study lasts for 24 weeks (6 months).
- It compares XXB750 to existing treatments and a dummy medicine.
- Researchers will check how well it works and if it's safe.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part.
However, there will be other specific health requirements that you'll need to meet. For example, the study will be looking for people who have been diagnosed with heart failure, and you might need to be taking certain existing medications or have specific health measurements.
A study doctor or nurse will carefully check your medical history and carry out some tests to see if this study is the right fit for you. It's important that you meet all the criteria to ensure the study is safe and helpful for everyone involved.
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?
- Have you been diagnosed with heart failure?
- Are you able to attend regular clinic visits for 24 weeks?
- Are you willing to receive study medication as an injection?
What does participation involve?
If you decide to take part in this study, it will last for a total of 24 weeks, which is about 6 months. Throughout this time, you will have several visits to the study clinic. These visits will involve various checks, such as physical examinations, blood tests, and vital signs like your blood pressure and heart rate.
You will be given the study medication, XXB750, or a comparison treatment (which could be existing heart failure medicines or a placebo, a dummy treatment with no active drug) as an injection. The study team will explain exactly how and when to take your medication. You'll start with a baseline visit, where initial measurements are taken, and then throughout the 24 weeks, there will be follow-up visits to monitor your health and how you're responding to the treatment. After the 24 weeks, there will be a final assessment to wrap up your participation.
Potential risks and benefits
Locations (11)
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedPortugal
- —UnverifiedSlovakia
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedHungary
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should. This can make you feel tired, breathless, and lead to swelling in your legs and ankles.
What is XXB750?
XXB750 is a new medicine being tested in this study to see if it can help people with heart failure.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers understand if the new medicine is truly effective.
How long will the study last?
Your involvement in the study will last for 24 weeks, which is about 6 months.
Will I know if I'm getting the new medicine or the placebo?
No, in this type of study, neither you nor your study doctor will know whether you are receiving XXB750, another active medication, or the placebo. This helps ensure fair results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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