A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Obesity.
This research study is testing a new potential medicine called AZD4144. It's for people who are overweight and interested in contributing to medical science. This is a very early-stage trial (Phase I), which means the main goal is to see if the medicine is safe and well-tolerated by the body. We'll also be looking at how the medicine works inside the body. Some participants will receive the active medicine, while others will receive a placebo – a dummy treatment with no active drug. Neither the participants nor the doctors will know who is getting which, to ensure the results are fair. Your participation could help us understand more about this new medicine and its potential future use.
At a glance
What is this study about?
This research study is about a new medicine called AZD4144. It's being developed to help people who are overweight. Being overweight can sometimes lead to other health problems, so new ways to help manage weight are always being explored. This particular study is in its very first stage, called Phase I. This means it's one of the first times this medicine is being tested in people. The main goals at this stage are to make sure the medicine is safe and doesn't cause too many side effects, and to understand how it behaves in the human body.
We're not expecting this medicine to be a cure for being overweight right now. Instead, we're trying to gather important information about it, like how much of it the body can handle and what effects it might have. This early information is really important because it helps scientists decide if the medicine is promising enough to continue with further, larger studies. Every new medicine goes through this careful process to ensure it's safe and effective before it can be widely used.
By taking part, you would be helping medical researchers learn more about this new medicine. While the study focuses on people who are overweight, the conditions mentioned (cardiorenal disease) are general health areas that can sometimes be linked to being overweight, and are often the focus of broader research efforts. Your contribution would be valuable in potentially bringing new treatment options to people in the future.
Key takeaways
- This is an early-stage study testing a new medicine (AZD4144) for people who are overweight.
- The main focus is on safety and how the medicine behaves in the body.
- Some participants will receive the new medicine, others a dummy treatment (placebo).
- Neither you nor the doctors will know who gets what until the study ends.
- You must be at least 18 years old to join, and both men and women are welcome.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women are welcome to take part. Researchers will check other things about your health to make sure this study is right and safe for you.
While the main goal is to test a new medicine for people who are overweight, the doctors will look at your overall health to make sure you can safely take part. This includes considering your medical history and current health status.
If you are interested, the study team will speak with you in detail about all the specific requirements and will perform some health checks to see if you are a good fit for this particular research.
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 able to attend clinic visits regularly?
- Are you comfortable potentially receiving a placebo (dummy treatment)?
- Do you understand this is an early-stage study focusing on safety, not a cure?
- Are you willing to discuss your full medical history with the study team?
What does participation involve?
If you decide to take part, you will be given the study medicine or a dummy treatment (placebo). You won't know which one you get, and neither will your study doctor, to keep the results fair. You'll need to attend several visits to the clinic. During these visits, doctors and nurses will check your health, ask you questions about how you're feeling, and take blood samples. You might also have other tests to see how the medicine is affecting your body. We don't have details on the exact number of visits or the total duration, but the study team will explain everything fully before you agree to join. They will also tell you if there is any follow-up after you stop taking the medicine.
Potential risks and benefits
Locations (1)
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Common questions
What is a Phase I study?
A Phase I study is the first step where a new medicine is tested in people. The main goal is to check if it's safe and how the body handles it, rather than if it works as a treatment.
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 fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor your study doctor will know whether you're receiving the active medicine or the placebo. This is called 'blinded' and helps ensure unbiased results.
Will this medicine cure my weight problem?
This is an early-stage study, so we don't know if the medicine will help with weight management. The main aim is to check its safety and how your body reacts to it.
Can I stop taking part in the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without having to explain why. 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
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