Active not recruitingPHASE3INTERVENTIONAL

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

This research study is investigating a new medicine called CagriSema, made by Novo Nordisk, to see how well it helps people with obesity lose weight over a long period. Doctors can't prescribe CagriSema yet. The study will last for three years in total, split into two parts. In the first two years, some participants will receive CagriSema, while others will get a 'dummy medicine' (placebo). Neither you nor your study doctor will know which treatment you are getting. For the final year, everyone will receive CagriSema, or if you were already on it, your dose might be adjusted. Like all medicines, CagriSema may have side effects, and the study will carefully monitor these. The main goal is to understand its long-term effects on weight loss.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

400

Start

10 Feb 2025

Estimated completion

31 Oct 2028

Obesity

What is this study about?

This study is trying to understand if a new medicine called CagriSema can help people living with obesity lose weight and keep it off over a long time. Obesity is a medical condition where having too much body fat can affect your health. Sometimes, diet and exercise alone aren't enough, and new medicines could offer more ways to help people.

CagriSema is a new medicine that isn't yet available from doctors. This study is an important step to see how safe and effective it is. It's compared against a "dummy medicine" (also called a placebo). This helps researchers be confident that any changes are due to CagriSema and not just other factors. By closely watching participants for three years, the study hopes to learn a lot about how well CagriSema works for long-term weight management.

The results of studies like this are vital. They help medical experts decide if new medicines should be approved for wider use. If successful, CagriSema could potentially offer another option for people living with obesity to manage their weight and improve their health.

Key takeaways

This study investigates a new weight loss medicine for obesity.
It lasts for three years and compares the new medicine to a dummy medicine.
Participants will not know which treatment they are receiving.
Close medical monitoring will be provided throughout the study.
The study helps understand the long-term effects of CagriSema on weight loss.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. You also need to have a body mass index (BMI) of 35 or higher. BMI is a way healthcare professionals assess if your weight is in a healthy range for your height.

There are some reasons why you might not be able to join. For example, if you have a certain level of sugar in your blood called HbA1c, measured by a blood test, you wouldn't be able to take part. Also, if you have ever been diagnosed with type 1 or type 2 diabetes, you would unfortunately not be eligible for this particular 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.

Are you 18 years old or older?
Do you have a Body Mass Index (BMI) of 35 or higher?
Have you ever been diagnosed with type 1 or type 2 diabetes? (If yes, you likely can't join)
Do you have any concerns about your blood sugar levels (HbA1c)? (This will be checked)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for a total of three years. For the first two years, you would be in the 'main phase'. During this time, you would either receive the new medicine, CagriSema, or a dummy medicine. What you receive will be decided by chance, like flipping a coin, and neither you nor your study doctor will know which one it is (this is called 'blinded').

After the first two years, you'll move into the 'extension phase' for another year. If you were taking CagriSema before, you'll either continue on it or slowly reduce your dose. If you were taking the dummy medicine, you'll switch to CagriSema during this final year. Again, the specific treatment in this phase is decided by chance and kept secret. Throughout the study, you would have regular visits to the clinic for check-ups, assessments, and to receive your study medicine.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new medicine before it's widely available, which could help manage your weight. You’ll also get close medical attention and monitoring throughout the study. However, like all medicines, CagriSema may have side effects, which the study will carefully track. There's also a chance you might receive the dummy medicine for the main part of the study, meaning you might not get the active treatment immediately. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual healthcare.

Locations (36)

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

Valley Clinical Trials
Verified postcode
Covina, United States
Diablo Clinical Research, Inc.
Verified postcode
Walnut Creek, United States
Yale University School Of Medicine
Verified postcode
New Haven, United States
East West Medical Research Institute_Honolulu
Verified postcode
Honolulu, United States
L-MARC Research Center
Verified postcode
Louisville, United States
StudyMetrix Research LLC
Verified postcode
City of Saint Peters, United States
Spartanburg Medical Research
Verified postcode
Spartanburg, United States
Holston Medical Group_Bristol
Verified postcode
Bristol, United States
North Texas Endocrine Center
Verified postcode
Dallas, United States
Washington Cntr Weight Mgmt
Verified postcode
Arlington, United States
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Verified postcode
Brussels, Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Verified postcode
Edegem, Belgium

Common questions

What is CagriSema?

CagriSema is a new medicine being developed to help people with obesity lose weight. It's not yet available from doctors.

What is 'dummy medicine'?

A 'dummy medicine', or placebo, looks just like the real medicine but contains no active ingredients. It helps researchers see if the actual medicine is truly working.

How long will I be in the study?

The study lasts for three years in total: two years for the main part and one year for the extension part.

Will I know if I'm getting the real medicine or the dummy medicine?

No, both you and your study doctor will not know which treatment you are receiving until after the study is over. This is common practice in clinical trials to ensure fair results.

What happens if I want to leave the study?

You can leave the study at any time, for any reason, without it affecting your medical care.