Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1 study assessing the pharmacokinetics of NEX-22A in subjects with T2D

This is a very early study, called a Phase 1 study, for people living with type 2 diabetes. The main aim is to find out what happens to a new medicine called NEX-22A once it's in the body. Researchers want to understand how it's absorbed, how it's broken down, and how it leaves the body. This information helps them work out the best way to give the medicine in the future. It’s a first step to see if this new treatment could eventually be helpful for people with type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Nanexa AB

Enrolment target

Start

15 May 2024

Type 2 diabetes

What is this study about?

This study is a Phase 1 trial, which means it's one of the very first times a new medicine (called NEX-22A) is being tested in people. The main goal of this type of study isn't to see if the medicine works to treat type 2 diabetes yet. Instead, it's about understanding how your body handles the medicine.

Researchers are interested in something called 'pharmacokinetics'. This fancy word simply means they want to track what happens to NEX-22A from the moment it enters your body until it leaves. They'll be looking at things like how quickly it gets into your bloodstream, how long it stays there, and how your body gets rid of it. This information is crucial for scientists to decide on the right dose and how often the medicine might need to be given in future studies.

So, why does this matter? By carefully studying how NEX-22A behaves in the body, researchers can make sure it's given in the safest and most effective way possible, if it proves to be a good treatment. It's a vital first step in the long process of developing new medicines for conditions like type 2 diabetes. This early stage helps lay the groundwork for potential future treatments.

Key takeaways

This is an early study of a new medicine for type 2 diabetes.
It helps researchers understand how the medicine works in your body.
Participation involves strict health checks and taking the study medicine.
You have the right to leave the study at any time.
Your health and safety are the top priority in this research.

Who may be eligible?

To be able to join this study, you must be an adult aged 18 years or older. The study is open to both men and women.

The most important requirement is that you have type 2 diabetes. The research team will check other specific health details to make sure the study is right and safe for you. These might include things like your general health, other medical conditions you have, or any medicines you are currently taking.

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?
Do you have a diagnosis of type 2 diabetes?
Are you comfortable potentially trying a new, experimental medicine?
Are you able to attend regular appointments at a clinic or hospital?

Answer every question to see your result.

What does participation involve?

The details about what taking part involves aren't fully described here, but generally, in a Phase 1 study like this, you can expect to have several appointments at a clinic or hospital. These visits will likely include blood tests to measure the new medicine in your system, and you might also have other health checks like blood pressure and heart rate measurements. You would be given the study medicine, NEX-22A. The complete length of time you'd be involved, from your first visit to your last follow-up, would be explained to you by the study team.

Potential risks and benefits

Taking part in a study like this means you might be among the first people to receive a new medicine. While the potential benefit is helping medical research and possibly contributing to new treatments for type 2 diabetes, there's no guarantee the medicine will improve your health. As with any new medicine, there's always a chance of side effects or risks, some of which may not be known yet. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is type 2 diabetes?

Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. It happens when the body doesn't produce enough insulin or the body's cells don't react to insulin properly.

What does 'Phase 1 study' mean?

A Phase 1 study is a very early stage of testing a new medicine in people. It mainly focuses on safety and how the body handles the medicine, rather than whether it treats the illness.

Will this medicine cure my diabetes?

The goal of this early study is not to cure diabetes, but to understand how the new medicine, NEX-22A, works within the body. It's a first step in developing new treatments.

What kinds of tests will I have?

While not fully detailed, Phase 1 studies often involve regular blood tests to check how the medicine is processed by your body, along with general health checks like blood pressure measurement.

Can I stop taking part if I change my mind?

Yes, you are always free to withdraw from the study at any point, and you don't need to give a reason. This will not affect your usual medical care.