Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c. (CagriSema s.c.) once-weekly in participants with overweight or obesity and type 2 diabetes

Researchers are conducting a study to test a new weekly injection called CagriSema. This medicine combines two drugs, cagrilintide and semaglutide. The study is for adults who have type 2 diabetes and are also overweight or obese. The main goal is to see how much weight people lose and if they achieve a significant weight reduction (at least 5%). The study will also look at how well the new medicine helps control blood sugar levels, changes in waist size, and overall quality of life. Importantly, it will monitor any side effects to make sure the treatment is safe. This is a large, advanced study, meaning the treatment has already been tested in earlier phases.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

422

Start

01 Jul 2024

Overweight and obesity and type 2 diabetes

What is this study about?

This study is looking into a new treatment called CagriSema, which is a combination of two existing medicines, cagrilintide and semaglutide. Both are given as a weekly injection under the skin. The main aim of the study is to see how effective and safe this new combination is for adults who have both type 2 diabetes and are overweight or obese.

The researchers want to find out if taking CagriSema helps people lose weight. Specifically, they'll be checking how much body weight changes and if people can achieve at least a 5% reduction in their weight. They are also interested in whether even bigger weight losses, like 20% or more, are possible.

Beyond weight loss, the study will also measure other important health markers. This includes changes in waist size, blood sugar control (measured by something called HbA1c), and blood pressure. They'll also monitor how the treatment affects a person's physical well-being and their quality of life. A very important part of any study is to carefully record any side effects or unwanted reactions to make sure the treatment is safe for people to use.

Key takeaways

The study tests a new weekly injection called CagriSema.
It's for adults with type 2 diabetes who are overweight or obese.
The main goals are to check weight loss and blood sugar control.
Safety and side effects are carefully monitored.
This is an advanced study (Phase III) to confirm benefits.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. The study is open to both men and women.

The main health conditions required to participate are having been diagnosed with type 2 diabetes, and also being considered overweight or obese.

There will be other detailed criteria, like specific medical history, current medications, and other health conditions, that the study doctors will review to decide if taking part is right and safe for you.

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?
Have you been diagnosed with type 2 diabetes?
Are you considered overweight or obese?
Are you willing to have weekly injections and attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive weekly injections of either the study medicine (CagriSema) or a placebo (a dummy treatment with no active medicine) for a set period. You would need to attend regular clinic visits where the study team will measure your weight, blood sugar levels, blood pressure, and waist size. They will also collect blood samples and ask you to complete questionnaires about your physical health and quality of life.

Throughout the study, the team will closely monitor you for any side effects. The total duration of the study hasn't been specified here, but clinical trials usually involve multiple visits over several months, or even longer, with follow-up appointments after you stop taking the study medicine.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medicine that could help with weight loss and improve your type 2 diabetes management, in addition to expert medical care and close monitoring of your health. However, like all medicines, the study drug could cause side effects or unwanted reactions. There might be some discomfort from injections or blood tests, and there's no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Ireland
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Unverified
Hungary
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Unverified
Austria
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Unverified
Poland
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Unverified
Germany

Common questions

What is CagriSema?

CagriSema is a new medicine being tested. It's a combination of two drugs, cagrilintide and semaglutide, given as a weekly injection.

What conditions is this study for?

This study is for adults who have been diagnosed with type 2 diabetes and are also considered overweight or obese.

What will researchers be measuring?

The main things they'll measure are changes in body weight, how well blood sugar is controlled, and any side effects. They'll also check waist size, blood pressure, and quality of life.

Is this a new type of study?

No, this is a 'Phase III' study, which means the treatment has already been tested in earlier phases and is now being looked at in a larger group of people to confirm its effectiveness and safety.

Will I definitely get the new medicine?

No, in this type of study, some participants receive the new medicine, while others receive a placebo, which is a dummy treatment. This helps researchers compare the effects.