Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study comparing the effect of different dosing conditions on blood levels of semaglutide in a new tablet composition in healthy participants

This research study is about a new tablet being developed for people with type 2 diabetes. The tablet contains a medicine called semaglutide. Scientists want to understand how different amounts (doses) of this new tablet affect how much semaglutide gets into the blood. To do this, they will be giving the tablets to healthy male volunteers and checking their blood. This is an early-stage study, meaning it’s one of the first times this new tablet form is being tested in people. The goal is to find out the best way to give the medicine so it can be effective for future patients with type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

120

Start

21 Jul 2023

Type 2 Diabetes

What is this study about?

Imagine you have a new type of medicine that comes in a tablet, and you want to make sure it works really well for people who need it. That's a bit like what this study is about. Scientists have developed a new tablet version of a medicine called semaglutide, which is used for type 2 diabetes. Before it can be used widely, they need to understand how the body handles it.

This study focuses on trying out different amounts of the new tablet in healthy people. The main thing they want to find out is how these different amounts affect the level of the medicine in the blood. Why is this important? Because getting the right amount of medicine into the blood is key to making sure it helps people without causing too many problems.

This kind of study is called a 'Phase I' study, which means it's an early step in testing a new medicine. It helps researchers gather important information about how safe the medicine is and how it acts in the body, which is vital before it can be tested in people who actually have type 2 diabetes.

Key takeaways

This study is testing a new tablet for type 2 diabetes.
It aims to understand how different amounts of the medicine work in the body.
It's an early-stage study in healthy male volunteers.
Participation involves receiving the medicine and having regular blood tests.
It's important for developing future treatments for diabetes.

Who may be eligible?

This study is looking for healthy men to take part. To be considered, you need to be at least 18 years old – there’s no upper age limit mentioned.

You won't be eligible if you're a woman, as this study is specifically for men. You also need to be generally in good health, as confirmed by the study doctors, because they want to understand how the medicine works in typical healthy bodies before testing it in patients with diabetes.

There might be other health checks or requirements that the study doctors will go through with you to make sure it's safe for you to take part.

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 a man?
Are you 18 years old or older?
Are you generally in good health?
Are you able to attend clinic visits as required?

Answer every question to see your result.

What does participation involve?

Details about taking part aren't fully described here, but typically, an early-stage study like this involves several visits to a clinic or hospital. You would likely receive the study tablet (semaglutide) and then have regular blood tests over a period of time to measure the medicine levels. You might also have other health checks like blood pressure and heart rate measurements. The total duration of your participation, including follow-up, would be explained by the study team. You would be told about any specific diet or activity restrictions you'd need to follow during the study.

Potential risks and benefits

Participating in research always has potential benefits and risks. A potential benefit of taking part in this study is contributing to medical understanding and the development of new treatments for type 2 diabetes, which could help many people in the future. As this is an early-stage study in healthy volunteers, there might not be a direct health benefit for you personally. Potential risks could include side effects from the study medicine, discomfort from blood tests, or inconvenience from clinic visits. You would be fully informed of all known and potential risks before deciding to take part. Remember, 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 semaglutide?

Semaglutide is a medicine that helps manage blood sugar levels, commonly used for type 2 diabetes.

Why is this study in healthy people?

It helps researchers understand how the new tablet works in the body before testing it in people who have diabetes.

Will I get paid to take part?

Payment for participation or compensation for travel expenses is often offered in these types of studies; you should ask the study team for details.

What if I feel unwell during the study?

The study team will monitor you closely, and you should always tell them immediately if you feel unwell.

How long will the study last for me?

The exact duration of your participation will be explained by the research team. It can vary, but generally, these early studies involve several weeks.