Control Of BioEquivalence with Xenical (COBEX): A Phase I, randomized, active-control study to evaluate EMP22 pharmacodynamics and EMP16 pharmacokinetics versus Xenical® in healthy volunteers.
This research study, called COBEX, is looking at how two new potential medicines, EMP22 and EMP16, work in the body compared to a well-known weight-loss drug called Xenical (orlistat). We're particularly interested in how much fat is passed in your poo when you take these medicines. This is important because medicines like Xenical work by stopping your body from absorbing some of the fat you eat. This study is in its early stages (Phase I) and involves healthy volunteers. The main goal is to understand how these new medicines affect your body and how they are absorbed, used, and cleared. This information helps us learn if they could be useful for treating obesity in the future.
At a glance
What is this study about?
This study, called COBEX, is a really important early step in understanding new treatments for obesity. Obesity is a condition where you have too much body fat, which can affect your health in many ways. Scientists are always trying to find new and better ways to help people manage their weight.
In this study, we're comparing two new potential medicines for obesity, called EMP22 and EMP16, with a medicine that's already approved and used, called Xenical (which contains the active ingredient orlistat). Medicines like Xenical work by preventing some of the fat you eat from being absorbed by your body. Instead, this unabsorbed fat leaves your body in your poo. By measuring how much fat is passed in your poo, we can understand how well these medicines are working.
This is a 'Phase I' study, which means it's one of the first times these new medicines (EMP22 and EMP16) are being tested in people. It involves healthy volunteers, rather than people who are overweight or obese. The main aim is to check how safe they are and how they behave in the body, such as how they are absorbed, how long they stay in your system, and how they affect the amount of fat passed in your poo. This helps researchers decide if these new medicines are promising enough to continue testing in larger studies with people who actually need treatment for obesity.
Key takeaways
- This study compares new potential obesity medicines with Xenical.
- It's an early-stage study for healthy adults aged 18 and over.
- The main aim is to understand how medicines affect fat absorption and how they work in the body.
- Participation involves taking medicine, following a diet, and providing blood and poo samples.
- You'll contribute important information for future obesity treatments.
Who may be eligible?
To join this study, we're looking for healthy adults. You need to be at least 18 years old – there's no upper age limit, as long as you're in good health.
Both men and women can take part in this study. The most important thing is that you are generally healthy and don't have any medical conditions that would make participating unsafe or complicate the results.
The research team will carry out a full health check to make sure the study is suitable for you. They will explain all the details and answer any questions you have before you decide to take part.
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 generally healthy, without any serious medical conditions?
- Are you able to follow specific diet instructions?
- Are you willing to provide blood and poo samples?
What does participation involve?
If you join this study, you'll be given either one of the new test medicines (EMP22 or EMP16) or Xenical. You'll switch between these different medicines during the study. You will likely need to stay at a research clinic for several periods, where your health will be closely monitored. During these stays, a special diet will be provided that contains a known amount of fat. We'll be collecting samples of your poo over a 24-hour period to measure how much fat you're passing. We'll also take regular blood samples to see how the medicines are absorbed and processed by your body. There will be several follow-up appointments after each period of taking the medicine to ensure you are well. The total time you'd be involved in the study, including all visits and observation periods, will be explained by the study team.
Potential risks and benefits
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Common questions
What is 'Xenical'?
Xenical is a medicine that helps with weight loss by stopping your body from absorbing some of the fat you eat. It's already approved and used by many people.
Why are you studying healthy volunteers?
In early-stage studies (Phase I), we often test new medicines in healthy volunteers first. This helps us ensure they are safe and understand how they work in the body before we test them in people with specific health conditions.
What does 'measuring fat in your poo' mean?
It means we'll collect samples of your poo (stool) over a day to measure how much fat is in it. This helps us see how well the medicine is working to prevent fat absorption.
Will I lose weight on this study?
This study is not designed for weight loss. While the medicines might affect fat absorption, the main goal is to understand how the medicines work, not to achieve weight loss in healthy volunteers.
Will I be compensated for my time?
Information about compensation for time and travel will be provided by the study team. Please ask them directly about this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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