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

A research study Looking into blood levels of the medicine NNC0519-0130 in the body of participants with normal or reduced kidney function

This research is all about a new potential medicine called NNC0519-0130, which is being developed for people living with Type 2 Diabetes. The main goal of this particular study is to understand how the body handles this new medicine, specifically how much of it gets into the bloodstream and how long it stays there. Researchers are especially interested in seeing if there are any differences in people with kidneys that are working normally compared to those whose kidneys aren't working as well. This information helps doctors understand the medicine better and work out the right dose for future use. It's an early study, which means it's one of the first times this medicine is being given to people.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Novo Nordisk A/S
Enrolment target
36
Start
04 Mar 2024

What is this study about?

You might have seen or heard about new medicines being developed. This particular study is an important early step for a new medicine called NNC0519-0130, which is being looked at as a possible treatment for Type 2 Diabetes. When a new medicine is created, scientists need to understand how it behaves once it's inside the human body. This is called 'human pharmacology' and it's a bit like getting to know a new friend – you need to understand how they work, what their habits are, and how they react in different situations.

The main thing this study wants to find out is how the body processes NNC0519-0130. Think of it like this: if you take a paracetamol, your body breaks it down and eventually gets rid of it. This study wants to measure how much of NNC0519-0130 gets into your blood, how long it stays there, and how quickly your body clears it out. This is really important information because it helps researchers work out the right amount (dose) of the medicine to give people in the future, so it can be effective but also safe.

The study is particularly interested in how kidney function affects the medicine. Our kidneys are like filters that help clear waste and medicines from our bodies. So, learning how NNC0519-0130 behaves in people with normal kidney function compared to those with reduced kidney function is vital. This knowledge ensures that when the medicine is given to a wider group of people later on, doctors will know if they need to adjust the dose for individuals with different kidney health, making sure it's as safe and effective as possible for everyone.

Key takeaways

  • It's an early study looking at a new medicine for Type 2 Diabetes.
  • Researchers want to understand how the medicine works in the body.
  • They are especially interested in how it affects people with different kidney health.
  • The study involves regular clinic visits and blood tests.
  • Your safety and wellbeing will be closely monitored.
  • You can ask questions and withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, at least 18 years old, with Type 2 Diabetes. There isn't an upper age limit, so people of many different ages can take part. Both men and women are welcome to participate in this research.

A key part of this study involves looking at how the new medicine affects people with different kidney functions. This means that researchers will be carefully checking your kidney health. Some participants will have kidneys that are working normally, while others will have kidneys that aren't working quite as well.

Because it's a medical study, there will be other health checks and rules to make sure it's safe for you to take part and that the results of the study are clear and reliable. These will be explained in detail by the study team.

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.

  1. Are you 18 years old or older?
  2. Do you have Type 2 Diabetes?
  3. Are you willing to have your kidney function checked?
  4. Are you able to attend regular clinic visits?
  5. Are you comfortable with having blood samples taken?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, NNC0519-0130. This is an early study, so it will involve several visits to the study clinic, likely over a period of weeks or months. During these visits, there will be various assessments. These will probably include regular blood tests to measure the levels of the medicine in your body, as this is the main focus of the study. You might also have other checks like blood pressure, heart rate, and general health examinations. The exact number of visits, tests, and the total duration of your participation will be fully explained by the study team before you make any decisions.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit could be helping scientists learn more about Type 2 Diabetes and contribute to the development of new treatments that could help many people in the future. As this is an early-stage study, the direct benefit to you from the new medicine isn't guaranteed, and it's possible you might not experience any improvement in your diabetes. Potential risks include side effects from the new medicine, which will be carefully monitored. Blood tests, for example, might cause slight discomfort or bruising. You will receive a detailed explanation of all known or potential risks before you decide to take part, and you always have the right to withdraw from the study at any time without giving a reason.

Locations (1)

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

Common questions

What is Type 2 Diabetes?

Type 2 Diabetes is a common condition where the body either doesn't produce enough insulin or doesn't use insulin effectively, leading to high blood sugar levels.

What does 'kidney function' mean in this study?

Kidney function refers to how well your kidneys are working to filter waste products, including medicines, from your blood. This study looks at different levels of kidney health.

Will this medicine cure my diabetes?

This is an early-stage study. Its main purpose is to understand how the medicine behaves in the body, not to provide a cure. While it aims to develop new treatments, a 'cure' isn't the direct goal of this phase.

Will I get paid to be in the study?

The study team will explain if there is any reimbursement for your time, travel, or other expenses. This varies between studies.

What happens after the study finishes?

After you complete the study, you will go back to your usual diabetes care with your own doctor. You won't continue to receive the study medicine.

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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