All studies
Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2.4 mg/2.4 mg) once weekly versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo in people with chronic kidney disease and type 2 diabetes living with overweight or obesity.

This research study is investigating a new combination medicine called CagriSema, which contains two active ingredients: cagrilintide and semaglutide. It's designed for adults aged 18 and over who have been diagnosed with both type 2 diabetes and chronic kidney disease, and who also live with overweight or obesity. The main goal is to understand how well CagriSema works compared to just semaglutide, just cagrilintide, or a placebo (dummy medicine). Researchers will measure changes in kidney function, body weight, and blood sugar levels. They will also carefully monitor for any side effects to ensure the medicine is safe. The study aims to find better ways to manage these serious health conditions.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Novo Nordisk A/S
Enrolment target
308
Start
15 Apr 2024

What is this study about?

This study is a medical research project trying to find new and better ways to help people who have type 2 diabetes and chronic kidney disease, especially if they also struggle with being overweight or obese. The main focus is on a new medicine called CagriSema. This isn't just one medicine, but a combination of two existing treatments, cagrilintide and semaglutide, given together in one weekly dose. Researchers want to see if this combination works better than taking each medicine separately, or compared to a 'placebo' – which is a dummy medicine containing no active ingredients.

The health of your kidneys is an important part of this study. The researchers will be looking closely at how the new medicine affects a measure called UACR (which checks for protein in your urine, a sign of kidney damage) and eGFR (which tells us how well your kidneys are filtering waste). They'll also be tracking other important health markers like changes in body weight, how much sugar is in your blood (measured by HbA1c), and your blood pressure. By checking all these things, the study aims to get a full picture of how CagriSema might help manage these complex health conditions.

Ultimately, this research is about improving treatment options. By carefully comparing CagriSema to other treatments and a placebo, medical experts hope to learn if this new combination could be a more effective way to help people with type 2 diabetes, kidney disease, and overweight or obesity to live healthier lives. Safety is always a top priority, so any side effects will be recorded and examined very carefully.

Key takeaways

  • This study evaluates a new combination medicine, CagriSema, for type 2 diabetes and kidney disease.
  • It aims to improve kidney health, blood sugar, and help with weight management.
  • Participants will receive either CagriSema, another active medicine, or a placebo.
  • Safety and potential side effects will be closely monitored by the research team.
  • The study could provide new treatment options for people with these conditions.

Who may be eligible?

This study is looking for adult volunteers aged 18 years and above. Both men and women are welcome to take part in this research.

To be considered for this study, you must have been diagnosed with two specific health conditions: type 2 diabetes and chronic kidney disease. Additionally, you should also be living with overweight or obesity. These are important criteria because the study is specifically designed to test the medicine in people with these particular health challenges.

It's important to understand that there will be other specific health requirements and checks to make sure the study is right and safe for you. These will be discussed in detail by the study team, but generally, the aim is to ensure participants are in a suitable health state for the type of treatment being investigated.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of type 2 diabetes?
  3. Do you have a diagnosis of chronic kidney disease?
  4. Are you currently living with overweight or obesity?
  5. Are you able to attend regular clinic appointments?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. During these visits, you would have various health checks and assessments, such as blood tests, urine tests, and blood pressure measurements. You would receive either the CagriSema combination medicine, semaglutide alone, cagrilintide alone, or a placebo (a dummy medicine with no active ingredients). All these study medicines are given as a weekly injection. The study team will provide training on how to administer the injection if it's done at home. There will be ongoing follow-up appointments to monitor your health and any side effects. The total duration of your participation will be explained fully by the study team.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as closely monitored care for your type 2 diabetes, kidney disease, and weight. If the new medicine is effective, it might help improve your health outcomes. However, there are also potential risks involved, such as experiencing side effects from the study medicine, which will be carefully monitored. You will be fully informed of all known and potential risks before deciding to join. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain
  • Unverified
    Hungary
  • Unverified
    Poland
  • Unverified
    Greece
  • Unverified
    Slovakia
  • Unverified
    France

Common questions

What is CagriSema?

CagriSema is an investigational medicine that combines two active drugs, cagrilintide and semaglutide. Researchers are studying how it may help people with type 2 diabetes, kidney disease, and overweight or obesity.

Why is this study important?

This study aims to find better treatments for the complex health challenges of type 2 diabetes, chronic kidney disease, and overweight or obesity. It could lead to new ways to improve kidney health and manage these conditions.

Will I definitely get the new medicine?

Not necessarily. Participants will be randomly assigned to receive either CagriSema, semaglutide alone, cagrilintide alone, or a placebo (dummy medicine). This helps researchers fairly compare the different treatments.

What kind of tests will be done?

You'll have regular blood and urine tests to check your kidney function, blood sugar, and other health markers. Your weight, blood pressure, and waist circumference will also be measured during your visits.

What if I experience side effects?

The study team will carefully monitor you for any side effects. You should report any new or worsening symptoms immediately. Your safety is a top priority throughout the study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.