Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A research study to look at how CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight

Researchers are conducting a study to understand more about a new medicine called CagriSema. This medicine is being investigated to see how it might help people who are overweight. The study will look specifically at whether CagriSema changes how much people eat, their feelings of hunger, and how fast food moves through their stomach. This is an early-stage study, meaning it's one of the first times this medicine is being tested in humans. The main goal is to learn how CagriSema works inside the body, rather than to see if it treats a condition. People aged 18 and over, of any gender, might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novo Nordisk A/S

Enrolment target

Start

09 Jan 2024

Obesity

What is this study about?

This research study is about a new medicine called CagriSema. Doctors and scientists want to understand exactly how this medicine works when people who are overweight take it. They're especially interested in three key areas: how it affects your food intake (meaning how much you eat), your appetite (how hungry you feel), and how quickly your stomach empties after you've eaten. By studying these things, they hope to get a clearer picture of how CagriSema might help with managing weight.

This is an early phase study, known as "Human Pharmacology." This means it's one of the very first times this particular medicine is being given to people. The main aim at this stage isn't to look for a cure or a specific treatment, but rather to learn important information about the medicine itself. Researchers want to find out how it behaves in the human body, how it's absorbed, where it goes, and how it affects different body functions.

Understanding these basic effects is a crucial step before the medicine can move on to larger studies to see if it can be an effective treatment for obesity. So, while it's not looking directly at weight loss in this study, the information gathered will be very important for future research into potential new ways to help people manage their weight.

Key takeaways

This study is testing a new medicine called CagriSema.
It aims to understand how CagriSema affects appetite, eating, and stomach emptying.
It's an early-stage study, focusing on how the medicine works in the body.
Adults aged 18 and over, of any gender, who are overweight, may be able to join.
Taking part involves clinic visits and controlled use of the study medicine.

Who may be eligible?

To be able to take part in this study, you would generally need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.

Both men and women are welcome to participate in this research. The study is specifically looking for people who are considered to have excess body weight or obesity.

Beyond these general points, there will be other specific health requirements and checks. These are put in place to make sure the study is safe for you and that the results they get are clear and accurate. You would need to discuss your full medical history with the study team to see if you meet all the criteria.

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 18 years old or older?
Do you have excess body weight or obesity?
Are you able to attend regular clinic visits?
Are you willing to take a new study medicine as instructed?
Do you understand that this is an early-stage research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would likely have several visits to the study clinic over a period of time. During these visits, the research team would carry out different assessments. This might include blood tests, checking your weight and other measurements, and possibly asking you to fill out questionnaires about your hunger and how much you eat.

You would be given the study medicine, CagriSema, as directed by the research team. This might be a pill or an injection, and they will explain exactly how to take it. The study team will monitor you closely to see how the medicine affects you. There will also be follow-up appointments after you've finished taking the medicine, to make sure you're well and to gather final information.

The total length of time you would be involved in the study, from your first screening visit to your last follow-up, would be clearly explained to you.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing valuable information that could help others in the future. You would also receive close medical attention from a study team. However, there are also potential risks; the new medicine might cause side effects, some of which might not be known yet. The study team will explain all known risks to you. Remember, joining is entirely your choice, and you have the right to leave the study at any time, for any reason, without it affecting your usual 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 CagriSema?

CagriSema is a new medicine being studied to understand how it affects the body, especially in people who are overweight.

Why are they studying this medicine?

Researchers want to learn how CagriSema influences eating habits, feelings of hunger, and how food moves through the stomach.

Will I lose weight by taking part?

This early study isn't designed to measure weight loss directly, but to understand how the medicine works in your body. Any weight changes would be noted.

Is this medicine available to the public yet?

No, CagriSema is a new medicine still in the early stages of research and is not available outside of clinical trials.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, and you don't need a reason.