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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A research study of a new medicine (NNC0650-0013) in healthy men

We are looking for healthy men to take part in an important early-stage research study. This study is testing a new medicine, called NNC0650-0013, for the very first time in people. The main goal is to understand if the medicine is safe and how it acts in the human body. This type of research is often the first step before larger studies can happen. The medicine being tested is thought to potentially help with managing weight and may also be useful for people with type 2 diabetes in the future. By participating, you could help scientists learn more about this new treatment.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Novo Nordisk A/S
Enrolment target
60
Start
22 Dec 2023

What is this study about?

This research study is about a new medicine, NNC0650-0013, that could potentially help people manage their weight and possibly even type 2 diabetes. This study is a very early stage of testing, often called a 'Phase I' study. This means it's the first time this specific medicine is being given to people, and it's being done in healthy volunteers. The main purpose at this stage isn't to see how well it treats a disease, but rather to carefully check if it's safe and how the body handles it.

Understanding how a new medicine works in the body, how quickly it's absorbed, and how it's removed, is a crucial step in drug development. By taking part, healthy volunteers help researchers gather this vital information. This early data then helps decide if the medicine is safe enough to be studied further in people who actually have weight management challenges or type 2 diabetes.

Since this is an early study, there isn't a lot of information available yet about the medicine, but this research is an important part of discovering new treatments that could one day make a difference to many people's health.

Key takeaways

  • This is an early study testing a new medicine in healthy people.
  • The medicine might help with weight management and type 2 diabetes.
  • Only men aged 18 and over, who are generally healthy, can take part.
  • The main goal is to check how safe the medicine is and how it works in the body.
  • Participants will be closely checked by doctors.

Who may be eligible?

To join this study, we are looking for men who are generally healthy. You need to be at least 18 years old – there is no upper age limit, meaning older men can also take part.

Since this is a very early stage study, it's common for researchers to start by testing new medicines in healthy people, rather than those with health conditions. This helps them understand the basic safety and how the medicine works without other health problems complicating the results.

Beyond being a healthy man aged 18 or over, other specific health checks will be done by the study team to make sure it's safe for you to participate.

Quick self-check
  • Are you a man?
  • Are you 18 years old or older?
  • Are you generally healthy?
  • Can you commit to regular clinic visits and possible overnight stays?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be given the new study medicine. This study usually involves several visits to a clinic, and you might need to stay overnight for some periods. During your time in the study, doctors and nurses will closely monitor your health. This includes regular check-ups, blood tests, and other assessments to see how your body is responding to the medicine.

The total amount of time you spend in the study will depend on its design, but early-stage studies often involve a period of taking the medicine and then follow-up appointments. All involved procedures and the exact duration will be fully explained before you agree to participate.

Potential risks and benefits

Taking part in any research study has potential risks and benefits. A potential benefit of taking part is contributing to medical science and helping to develop new medicines that could improve health for others in the future. For the healthy volunteers in this early study, there isn't a direct personal health benefit expected from the medicine itself. Potential risks include experiencing side effects from the new medicine, which are not fully known yet, or discomfort from medical procedures like blood tests. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Germany

Common questions

What is a 'Phase I' study?

It's the first time a new medicine is tested in people, usually healthy volunteers, to check its safety and how the body handles it.

Will I get paid to participate?

Many early-stage studies offer payment for your time and inconvenience. This will be discussed with you before you agree to join.

What kind of medicine is NNC0650-0013?

It's a new medicine being developed that might help with weight management and type 2 diabetes, but it's very early in its testing.

Do I have to be unwell to join?

No, this particular study is looking for generally healthy men, not people with existing conditions.

What if I change my mind during the study?

You can leave the study at any time without giving a reason, and it won't 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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