Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor

This important study is investigating a new combination treatment called CagriSema for adults living with type 2 diabetes. Participants currently take metformin, and some might also be taking an SGLT2 inhibitor, but their diabetes isn't fully controlled. The study aims to see if CagriSema, made up of two medicines (cagrilintide and semaglutide) given as a weekly injection, is more effective than semaglutide alone, cagrilintide alone, or a placebo (dummy treatment). Researchers will carefully watch changes in blood sugar levels (HbA1c) and body weight over 68 weeks to understand how well CagriSema works and if it's safe to use. This is a crucial step in potentially finding better ways to manage type 2 diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

1,223

Start

30 Oct 2023

Type 2 diabetes

What is this study about?

This study is designed to help us understand a new potential treatment for people with type 2 diabetes. You might already be taking medicine like metformin, and possibly another called an SGLT2 inhibitor, but your blood sugar levels might still be a bit too high. This new treatment, called CagriSema, combines two existing medicines, cagrilintide and semaglutide, into a single weekly injection. The aim is to see if this combination works better than taking each medicine on its own, or compared to a dummy treatment (placebo).

The main focus of the study is to check how well CagriSema helps to lower and control blood sugar levels, measured by something called HbA1c. Researchers will also be looking closely at how the treatment might affect body weight. This is a 'Phase III' study, which means it's a large and important step to confirm the effectiveness and safety of CagriSema before it can become widely available. The study will last for 68 weeks, during which participants will be closely monitored.

Finding new and more effective ways to manage type 2 diabetes is very important. This condition can lead to other health problems if blood sugar levels aren't kept under control. By carefully studying CagriSema, we hope to gather valuable information that could lead to improved treatment options, helping people with type 2 diabetes live healthier lives.

Key takeaways

This study is testing a new combination medicine, CagriSema, for type 2 diabetes.
It aims to see if CagriSema is better at controlling blood sugar and helping with weight loss.
Participants will receive weekly injections for 68 weeks.
Both men and women aged 18 and over with 'uncontrolled' type 2 diabetes can join.
Close medical monitoring is provided throughout the study.

Who may be eligible?

This study is looking for adults who are 18 years old or older. Both men and women can take part.

To be considered for the study, you must have type 2 diabetes, and your current treatment (metformin, with or without an SGLT2 inhibitor) isn't fully controlling your blood sugar levels.

There will be other detailed health checks to make sure the study is safe and suitable for you. These will be explained fully by the study team.

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 type 2 diabetes?
Are you currently taking metformin (and possibly an SGLT2 inhibitor)?
Are your blood sugar levels still not as controlled as your doctor would like?
Are you able to attend regular clinic visits for 68 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive a weekly injection of either CagriSema (the new combination medicine), semaglutide alone, cagrilintide alone, or a placebo (a dummy injection that contains no active medicine). Which treatment you receive is decided by chance, like flipping a coin, so neither you nor the study team will know which one you are getting. Everyone will continue taking their metformin, and if applicable, their SGLT2 inhibitor.

You will have regular visits to the clinic over a period of 68 weeks. At these visits, the study team will take blood samples to check your blood sugar (HbA1c) and other health markers, measure your weight, and check your blood pressure. They will also ask you about how you are feeling and any side effects you might be experiencing. There will be initial screening visits to confirm you're eligible, followed by the treatment period, and then a final follow-up after your last dose. All study-related medication and assessments will be provided at no cost.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment that could help manage your diabetes and weight more effectively than your current medicines, or receiving very close medical monitoring. However, there are also potential risks, including side effects from the study medicines, which will be fully explained to you. It's also possible you may receive a placebo or a medicine that is not as effective for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

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

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Unverified
Denmark
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Unverified
Sweden
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Unverified
Slovakia
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Unverified
Hungary
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Unverified
Poland
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Unverified
Czechia
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Unverified
Germany
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Unverified
Finland
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Unverified
Italy
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Unverified
Spain
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Unverified
Greece
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Unverified
Croatia

Common questions

What is CagriSema?

CagriSema is a potential new medicine that combines two diabetes treatments, cagrilintide and semaglutide, into one weekly injection.

What does 'HbA1c' mean?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's a key measure for how well diabetes is being managed.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the study team will know which specific treatment you are receiving until after the study ends.

How long does the study last?

The treatment part of the study lasts for 68 weeks, which is about a year and a half. There will also be some initial checks and a final follow-up visit.

Will this study cure my diabetes?

Clinical trials like this aim to find better ways to manage conditions, not necessarily cure them. The goal is to see if CagriSema can help control blood sugar and weight more effectively.