Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) once weekly versus placebo in participants with type 2 diabetes and painful diabetic peripheral neuropathy
Many people with type 2 diabetes develop diabetic nerve damage, known as peripheral neuropathy. This often causes burning, tingling, or shooting pain in the feet, legs, or hands, which can be hard to treat. This Phase II research study tests a new treatment called CagriSema. CagriSema combines two medicines, cagrilintide and semaglutide, given as a single weekly injection under the skin. Researchers want to see if CagriSema can safely reduce daily nerve pain compared to a dummy treatment (a placebo). The trial will also monitor how the treatment affects blood sugar levels, body weight, sleep quality, blood pressure, and cholesterol. Half of the participants may receive CagriSema and half may receive a placebo, chosen at random. By taking part, volunteers help doctors discover whether this new medicine offers a better way to manage both diabetes and persistent nerve pain.
At a glance
What is this study about?
Type 2 diabetes can affect the body in many ways, especially over time. One common complication is diabetic peripheral neuropathy, which happens when high blood sugar damages the small nerves, usually in the feet and legs. This can cause persistent burning, shooting pain, numbness, and tingling. It often disrupts sleep and makes daily activities painful and exhausting. Current treatments do not work for everyone and can carry unwanted side effects.
This trial investigates a new combination medicine called CagriSema. It brings together two active drugs: semaglutide (which is already widely used to manage blood sugar and weight) and cagrilintide (a newer medicine that helps regulate appetite and metabolism). Researchers believe this combination may help calm nerve pain while also improving diabetes management.
Because this is an exploratory (Phase II) trial, doctors are looking closely at how well the medicine works and how safe it is. They will measure whether participants feel meaningful pain relief—such as a 30% or 50% drop in their usual pain levels—and whether their sleep and mobility improve.
Finding new ways to tackle nerve pain is crucial. If CagriSema proves effective, it could offer a dual benefit: helping people keep their diabetes under control while easing the chronic, distressing pain that holds them back in everyday life.
Key takeaways
- Tests whether CagriSema can reduce painful diabetic nerve damage.
- Compares a once-weekly injection against a dummy (placebo) injection.
- Open to adults aged 18 and over with type 2 diabetes and nerve pain.
- Monitors pain relief, sleep quality, blood sugar, weight, and blood pressure.
- Participation is voluntary, and you are closely looked after by a specialist medical team.
Who may be eligible?
This trial is open to men and women aged 18 and over who have been diagnosed with type 2 diabetes and experience ongoing nerve pain in their legs, feet, or hands. Your pain should be directly linked to diabetic neuropathy rather than another condition, like a trapped nerve in your back.
To join, your diabetes will need to be reasonably stable, and you must be willing to track your daily pain levels using a simple rating scale. You should also be able and willing to attend regular clinic appointments and take a weekly injection at home.
You may not be eligible if you have type 1 diabetes, severe kidney problems, certain other nerve diseases, or if you are currently taking part in another clinical trial. The study doctors will review your complete medical history and current medications before confirming if the trial is safe and suitable 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.
- I am aged 18 or older.
- I have been diagnosed with type 2 diabetes.
- I have regular burning, tingling, or shooting pain in my feet, legs, or hands.
- I am comfortable giving myself a once-weekly injection (or having a carer help).
- I am happy to attend regular clinic check-ups and record my pain levels.
What does participation involve?
If you take part, you will be randomly assigned by computer to receive either CagriSema or an inactive placebo (dummy injection). Neither you nor the study team will know which one you are receiving until the trial ends. The medicine is taken once a week as an injection just under the skin of your tummy or thigh, using an easy-to-use pen device.
You will attend regular clinic visits throughout the study. During these visits, the team will check your blood pressure, test your blood sugar and cholesterol, check your weight, and examine your feet. You will also complete short questionnaires about your pain levels, sleep, and how your symptoms affect your daily life.
You will be asked to keep a daily or weekly diary to score your pain on a simple scale from 0 to 10. The trial team will support you closely, monitoring your health and any side effects throughout the entire study period, which typically lasts several months.
Potential risks and benefits
Locations (4)
- —UnverifiedNorway
- —UnverifiedDenmark
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is CagriSema?
CagriSema is a trial medicine that combines two drugs—cagrilintide and semaglutide—designed to work together to lower blood sugar, manage weight, and potentially ease nerve pain.
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active drug. Comparing CagriSema to a placebo helps scientists prove whether any health improvements are truly caused by the new medicine.
Will taking part cost me anything?
No, the trial medicine and all related tests are provided free of charge. Most clinical trials also help cover reasonable travel expenses to and from the study clinic.
Can I continue taking my usual diabetes medicines?
In many cases, yes. The study doctor will check all your regular prescriptions to ensure they can be taken safely alongside the trial treatment.
Can I stop taking part if I change my mind?
Yes, absolutely. You can leave the trial at any point, for any reason, without it affecting your standard medical care or your relationship with your doctor.
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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