Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. once weekly versus tirzepatide 5 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both
Living with type 2 diabetes often means trying different treatments to keep blood sugar levels in a safe range. This clinical trial is testing a new weekly injection called CagriSema, which combines two active medicines (cagrilintide and semaglutide). Researchers are comparing it directly against another widely used diabetes injection called tirzepatide (brand name Mounjaro). The trial is designed for adults whose current diabetes tablets, such as metformin or SGLT2 inhibitors, are no longer keeping their blood sugar fully under control. Over 60 weeks, researchers will measure how well each medicine lowers blood sugar (HbA1c) and whether it helps participants lose weight. They will also look at heart health markers such as blood pressure and cholesterol. The findings will help doctors understand which treatment offers the best support for people with type 2 diabetes.
At a glance
What is this study about?
Type 2 diabetes is a common, long-term condition where the body struggles to control the amount of sugar in the blood. Over time, high blood sugar can increase the risk of serious health issues, including heart problems, nerve damage, and eye conditions. While lifestyle changes and daily tablets like metformin help many people, these medicines do not always keep blood sugar at ideal targets as time goes on.
This trial is looking at a new treatment called CagriSema. It is a once-weekly injection that combines two medicines: cagrilintide and semaglutide. Both work by copying natural gut hormones that help the pancreas release insulin, reduce appetite, and make you feel fuller after eating. In this study, CagriSema is being compared against tirzepatide (known as Mounjaro), an approved once-weekly diabetes injection that also targets natural gut hormones.
By comparing these two treatments head-to-head over 60 weeks, researchers hope to see which one is more effective at lowering blood sugar (measured by an HbA1c blood test) and promoting weight loss. The trial also monitors changes in blood pressure, cholesterol, and waist size, giving doctors valuable evidence to choose the most effective care in the future.
Key takeaways
- The trial compares two weekly injections for type 2 diabetes: CagriSema and Mounjaro (tirzepatide).
- It is for adults whose blood sugar remains high on metformin or SGLT2 inhibitor tablets.
- The study lasts for 60 weeks and tracks changes in blood sugar (HbA1c) and body weight.
- There is no placebo; every participant receives an active diabetes medication.
- Participation is voluntary, and you can withdraw at any point without impacting your care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with type 2 diabetes. It is designed specifically for people whose blood sugar levels remain higher than desired, even though they are already taking standard diabetes tablets such as metformin, an SGLT2 inhibitor, or a combination of both.
People of all genders can take part. However, you will need to meet certain health checks to ensure the study is safe for you. For instance, people with certain other serious health conditions or specific medical histories may not be able to join.
A trial doctor will review your complete medical background, current medications, and everyday health before confirming whether you can 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.
- I am aged 18 or older.
- I have been diagnosed with type 2 diabetes.
- I currently take metformin, an SGLT2 inhibitor, or both for my diabetes.
- My blood sugar levels are still higher than my target range.
- I am comfortable using a once-weekly injection pen at home.
What does participation involve?
Taking part in this study lasts for around 60 weeks (about 14 months). During this time, you will be randomly assigned to receive either CagriSema or tirzepatide (Mounjaro). Both medicines are given once a week using a pre-filled injection pen into the skin, usually in the tummy or thigh, and the study team will show you how to do this safely.
You will have regular appointments at a local study clinic. These visits will involve standard health checks, such as measuring your weight, waistline, and blood pressure. You will also have routine blood tests to check your average blood sugar levels (HbA1c), fasting sugar levels, and cholesterol.
The research team will stay in touch between visits to check how you are feeling and see if you have any side effects. You can continue your normal daily activities while on the trial.
Potential risks and benefits
Locations (6)
- —UnverifiedRomania
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedPoland
Common questions
What is CagriSema?
CagriSema is a trial medicine that combines two drugs—cagrilintide and semaglutide—into a single weekly injection to help control blood sugar and support weight loss.
Will I receive a dummy injection (placebo)?
No, this is an active-comparison study. You will receive either CagriSema or tirzepatide (Mounjaro); neither group receives a dummy medicine.
How often do I need to take the medicine?
Whichever treatment you are given, it is injected once a week under the skin using a simple, pre-filled pen.
Do I have to pay to take part?
No. The study medication, clinic visits, and all trial-related tests are provided free of charge, and travel expenses are often covered.
Can I leave the study if I change my mind?
Yes. You are free to stop participating at any time. Leaving the trial will not affect your relationship with your usual doctors or your normal treatment.
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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