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RecruitingPHASE3INTERVENTIONAL

A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

This research study is investigating two different medicines for weight loss: CagriSema and Semaglutide. CagriSema is a new medicine being tested, while Semaglutide is already available to doctors. The study aims to understand how safe and effective these treatments are for people living with obesity, including those who also have type 2 diabetes. Participants will be randomly assigned to receive one of the medicines, meaning it's decided by chance which treatment they get. The study will last for approximately 83 weeks. This research hopes to find better ways to help people manage their weight and health.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Novo Nordisk A/S
Enrolment target
2,500
Start
21 May 2026
Estimated completion
19 Apr 2028

What is this study about?

This research study is about finding new ways to help people who are living with obesity to lose weight. Sometimes, people with obesity also have type 2 diabetes, and this study includes them too. The main goal is to look at a new medicine called CagriSema and compare it to a medicine doctors can already prescribe, called Semaglutide. The researchers want to understand how well CagriSema works for weight loss and how safe it is for people to use, especially compared to Semaglutide.

You might be wondering why this study is important. Obesity can lead to various health problems, and finding safe and effective ways to manage weight is crucial for many people. By comparing a new medicine with an existing one, the study can give us valuable information about the best ways to help people improve their health.

Taking part in a study like this means you would receive one of the study medicines. Which one you get is decided by chance, like flipping a coin. The study will follow participants for about 83 weeks to see the effects of the medicines over time.

Key takeaways

  • This study is testing new and existing medicines for weight loss in people with obesity.
  • It includes people with and without type 2 diabetes.
  • Participation involves receiving one of two medicines and regular health checks for about 83 weeks.
  • You will be randomly assigned to receive either CagriSema (new) or Semaglutide (existing).
  • Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old. Your body mass index (BMI), which is a measure of your weight compared to your height, needs to be 35 or higher. This study welcomes both men and women, including people of all gender identities.

If you have type 2 diabetes, your average blood sugar level (HbA1c) needs to be below 10%. If you don't have type 2 diabetes, your HbA1c should be below 6.5%. If during the initial health checks your HbA1c is 6.5% or higher and you didn't know you had diabetes, your doctor would need to confirm if you have type 2 diabetes before you could join.

There are also some reasons why you might not be able to join. For example, if your weight has changed by more than 5% in the last three months, or if you've taken certain types of weight-loss medicines (like some GLP-1 medicines or amylin-like medicines) within the last six months, you wouldn't be able to take part in this specific study.

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. Is your body mass index (BMI) 35 or higher?
  3. Have you *not* had a weight change of more than 5% in the last 3 months?
  4. Have you *not* used certain weight-loss medicines (like some GLP-1s) in the last 6 months?
  5. If you have type 2 diabetes, is your HbA1c (average blood sugar) below 10%?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If you do, you'd then be randomly assigned to receive either the new medicine CagriSema or the existing medicine Semaglutide. This 'random assignment' means it's decided by chance which treatment you get, ensuring fairness in the study.

You would regularly receive your study medication and attend scheduled visits for health checks. These check-ups would involve assessments like measuring your weight, blood tests, and discussions about how you're feeling and any side effects you might be experiencing. The study team will explain everything clearly, and you'll have opportunities to ask questions. The total time you'd be involved in the study is about 83 weeks, which is roughly a year and eight months, including regular follow-ups.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving expert medical monitoring and potentially losing weight with a new or established treatment. However, all medicines carry potential risks and side effects, which will be fully explained to you before you decide to join. It's important to remember that you are a volunteer and can choose to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (303)

  • Uni of Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Not yet recruiting
  • Cahaba Research
    Verified postcode
    Pelham, United States· Recruiting
  • Elligo Health Research Inc
    Verified postcode
    Gilbert, United States· Not yet recruiting
  • Velocity Clinical Research-Phoenix
    Verified postcode
    Phoenix, United States· Recruiting
  • Arkansas Clinical Research
    Verified postcode
    Little Rock, United States· Recruiting
  • Woodland Int. Research Group
    Verified postcode
    Little Rock, United States· Not yet recruiting
  • Headlands Research California, LLC
    Verified postcode
    Escondido, United States· Recruiting
  • Neighborhood Healthcare
    Verified postcode
    Escondido, United States· Recruiting
  • Diabetes & Endocrine Specialists - La Mesa
    Verified postcode
    La Mesa, United States· Recruiting
  • Clinical Trials Research_Sacramento
    Verified postcode
    Lincoln, United States· Recruiting
  • Loma Linda University Faculty Medical Clinics
    Verified postcode
    Loma Linda, United States· Not yet recruiting
  • Pacific Clinical Studies
    Verified postcode
    Los Alamitos, United States· Recruiting

Common questions

What is CagriSema?

CagriSema is a new medicine being tested in this study to see if it helps people with obesity lose weight.

What is Semaglutide?

Semaglutide is a medicine that doctors can already prescribe to help with weight loss and manage type 2 diabetes.

How long does the study last?

The study will last for about 83 weeks, which is roughly a year and eight months.

Will I know which medicine I'm getting?

No, it's decided by chance (randomly) whether you receive CagriSema or Semaglutide, to ensure fair comparison.

Can I leave the study at any time?

Yes, you are a volunteer and can withdraw from the study at any point without it affecting your regular medical care.

How to find out more

Novo Nordisk

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Research Study to Look at How Two Different Doses of Cagri…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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