A study to see the effect of NNC0194-0499 alone or in combination with semaglutide on blood sugar control in people living with type 1 diabetes.
Living with type 1 diabetes means constantly balancing insulin and blood sugar levels. This early-stage clinical trial is testing an experimental medicine called NNC0194-0499 in adults with type 1 diabetes. Researchers want to find out how it affects blood sugar control and how safe it is to use. The study also looks at what happens when NNC0194-0499 is taken alongside semaglutide, an approved medicine that can help manage blood sugar and appetite. Because this is a Phase 1 study, the main focus is on safety, side effects, and learning how the body processes the medicines. Participants will be closely monitored by a team of doctors and nurses throughout the trial. Taking part is completely voluntary, and the findings may help scientists develop new treatment options to support people with type 1 diabetes in the future.
At a glance
What is this study about?
Type 1 diabetes is a lifelong condition where the body cannot make its own insulin, leading to high blood sugar levels. People manage it with daily insulin injections or an insulin pump. Even with modern insulin, keeping blood sugar in a healthy range can be tough. Researchers are constantly looking for new medicines that can work alongside insulin to make blood sugar easier to manage and protect long-term health.
This study tests a new experimental drug, currently known as NNC0194-0499. The research team wants to see how this medicine affects blood sugar levels in adults with type 1 diabetes. They are also testing it in combination with semaglutide, a medicine well known for helping people with type 2 diabetes control their blood sugar and weight.
This is an early-phase trial, meaning it is one of the first times this combination is being tested in people with type 1 diabetes. The primary goal is to ensure the treatments are safe, find out what side effects might happen, and understand how the medicines act in the body. While it may not directly improve a participant's own health, the results will provide vital clues for future diabetes treatments.
Key takeaways
- Testing a new experimental drug (NNC0194-0499) alone and with semaglutide.
- Aimed at adults aged 18 and older living with type 1 diabetes.
- This is an early-stage study focusing primarily on safety and blood sugar effects.
- Participants will continue to take insulin and receive close expert monitoring.
- Taking part is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with type 1 diabetes. Both men and women can take part.
Because this is an early-stage safety trial, participants will need to meet strict health criteria. The study team will check your overall health, your current diabetes management, and whether your blood sugar levels are within an acceptable range for the study.
You may not be able to join if you have certain other medical conditions, severe complications from diabetes, or if you are taking specific medications that could interfere with the study drugs. Women who are pregnant or planning to become pregnant are usually not eligible.
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.
- I am 18 years of age or older.
- I have been diagnosed with type 1 diabetes.
- I currently take insulin to manage my blood sugar.
- I am able and willing to attend regular clinic visits for health checks.
- I am not currently pregnant or planning a pregnancy.
What does participation involve?
If you take part, you will be invited to a research clinic for several visits over a few weeks or months. At the start, the team will run health checks, such as blood tests, heart traces (ECGs), and physical exams, to make sure the trial is safe for you.
During the study, you will receive doses of the trial medicine (NNC0194-0499) either alone or with semaglutide, likely given as injections. You will continue to manage your type 1 diabetes with insulin under close medical guidance. You will need to check your blood sugar levels regularly, attend scheduled clinic check-ups, and keep a diary of any symptoms or side effects.
After you finish taking the trial medicine, there will be follow-up appointments so the doctors can check that you are well and that any effects of the medicine have worn off.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
Will I still need to take my normal insulin?
Yes. This study medicine is designed to be tested alongside diabetes care, not to replace insulin. You will continue taking insulin as advised by the study doctors.
What is semaglutide?
Semaglutide is a medicine already widely used for type 2 diabetes and weight management. This study tests how it works together with a new drug in type 1 diabetes.
What is an early-stage (Phase 1) trial?
Phase 1 is an early step in testing a new treatment in humans. It focuses mainly on finding out how safe the medicine is, what dose works best, and what side effects it might cause.
Do I have to pay to take part?
No. The trial medicines, tests, and doctor visits are provided free of charge. Travel expenses to and from the clinic are often reimbursed.
Can I leave the study if I change my mind?
Yes, absolutely. You can leave the study at any point without giving a reason, and your regular NHS medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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