Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study of a new medicine NNC0363-1063 in participants with type 1 diabetes

This research study is investigating a new medication called NNC0363-1063 for adults aged 18 and above who live with type 1 diabetes. It's a very early-stage study, sometimes called a Phase I study. This means researchers are focusing on understanding how the new medicine acts in the human body, how it's absorbed, and if it's safe at different doses. They are not yet looking at whether it cures or effectively treats type 1 diabetes, but rather gathering important initial information that will help decide if it can be studied further in the future. The study is open to both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

20 Nov 2025

Diabetes type 1

What is this study about?

This study is exploring a new medicine called NNC0363-1063. It's specifically for people who have type 1 diabetes. You might be hearing about this medicine for the first time, as it's quite new.

The main goal of this particular study is to learn more about how the new medicine behaves inside the human body. This includes understanding how it's absorbed, how long it stays in the body, and how it's processed. Researchers also want to find out if it's safe and well-tolerated at different doses. This type of research is a crucial first step when developing any new medicine.

Because this is an early-stage study, it's not designed to test if the medicine can treat your type 1 diabetes yet. Instead, the information gathered here will help researchers decide if it's safe and promising enough to continue with larger studies in the future that would then look at its potential benefits for people with type 1 diabetes.

Key takeaways

This study is testing a new medicine for type 1 diabetes called NNC0363-1063.
It's an early-stage study focused on safety and how the medicine acts in the body.
Adults aged 18 and over with type 1 diabetes can take part.
Participation involves taking the medicine and regular clinic visits for health checks.
The study aims to gather important information for future research, not to cure diabetes.

Who may be eligible?

This study is looking for volunteers who are adults, meaning you must be at least 18 years old to take part. There is no upper age limit, so adults of any age can be considered.

It's important that you have a confirmed diagnosis of type 1 diabetes. The study is open to both men and women.

There will be other health requirements and checks to make sure the study is right and safe for you. These will be discussed in detail by the study team.

Quick self-check

Are you 18 years old or older?
Do you have type 1 diabetes?
Are you able to attend regular clinic appointments?
Are you willing to take a new study medicine as instructed?
Are you comfortable with blood tests and other routine health checks?
Have you discussed this with your doctor?

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 would receive the new study medicine, NNC0363-1063. The study team would explain exactly how and when to take it. You would also have regular visits to the clinic, where doctors and nurses would perform various health checks such as blood tests, urine tests, and possibly measure your blood pressure and heart rate. These assessments help them understand how your body is reacting to the medicine.

There might be a period of close monitoring, potentially including staying overnight at the clinic for certain assessments. After receiving the medicine, you'll have follow-up visits or calls to check on your health and any side effects. The total length of your participation would be fully explained before you agree to join.

Potential risks and benefits

Taking part in any research study has potential benefits and potential risks. A possible benefit is helping scientists learn more about type 1 diabetes and a new medicine, which could eventually lead to better treatments for more people. You would also receive close medical attention during the study. However, because this is a new medicine, there are unknown risks and potential side effects that researchers are trying to identify. These will be fully explained to you before you decide. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is 'Phase I' in a clinical trial?

Phase I is the very first stage where a new medicine is tested in people. The main goal is to check its safety, how it's absorbed, and if there are any side effects, rather than how well it treats a condition.

Will this medicine cure my type 1 diabetes?

No, this early-stage study is not designed to test if the medicine cures type 1 diabetes. Its purpose is to gather basic information about safety and how it works in the body.

Do I have to stop my current diabetes medication if I join?

This would depend on the study's specific rules. The research team will tell you if any changes to your current medication are required and why, before you agree to participate.

Who is paying for this research?

Clinical trials are typically funded by pharmaceutical companies, government grants, or other research organisations. The study team can provide details on who is sponsoring this specific research.

What if I experience side effects during the study?

You would be closely monitored by the study team. Any side effects should be reported immediately, and the team will provide medical care and guidance throughout your participation.