All studies
Active not recruitingPHASE3INTERVENTIONAL

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

This study is looking into a new medicine called Cagrilintide, which might help people who are overweight or have obesity to lose weight. It's a 'Phase 3' trial, meaning it's a later stage of testing. Participants will either receive Cagrilintide or a placebo (a dummy medicine) by chance, with more people getting the actual medicine. The study aims to understand how effective Cagrilintide is at reducing body weight. This new medicine isn't available from doctors yet. Like all medicines, there could be side effects, which will be carefully monitored. Taking part would last about 1 year and 6 months.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Novo Nordisk A/S
Enrolment target
300
Start
05 Nov 2025
Estimated completion
29 Jun 2027

What is this study about?

This study is about a new medicine called Cagrilintide, and its main goal is to find out how well it helps people who are overweight or have obesity to lose weight. Many people find it difficult to lose weight and keep it off, even after trying diets. This research hopes to find a new way to support weight loss.

Participants in the study will be split into two groups by chance. Some will receive the new medicine, Cagrilintide, and others will receive a placebo. A placebo looks like the real medicine but contains no active ingredients; it helps researchers compare the effects of the new drug more accurately. About two-thirds of participants will receive Cagrilintide.

This is a 'Phase 3' study, which means the medicine has already undergone earlier tests and is now being studied in a larger group of people before it can be considered for wider use. It's important to remember that Cagrilintide is not yet available as a prescription medicine from your doctor.

Key takeaways

  • The study is testing a new weight-loss medicine called Cagrilintide.
  • It's for adults living with overweight or obesity.
  • Participants will either get the new medicine or a dummy treatment (placebo).
  • Each person will be in the study for about 18 months.
  • Possible side effects will be carefully watched and recorded.
  • Cagrilintide is not yet available as a prescription medicine.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. You should also have tried to lose weight through diet at least once before without success. We are looking for people who are living with overweight or obesity.

Specifically, your Body Mass Index (BMI) needs to be 30 or higher. If your BMI is between 27 and 30, you might still be able to join if you also have a weight-related health condition like high blood pressure, high cholesterol, sleep apnoea, or heart disease.

However, you cannot take part if you have type 1 or type 2 diabetes. Also, if you've recently used (in the last 6 months) or plan to use any other medication specifically for weight management, or if you've previously taken certain types of amylin-based medicines, you wouldn't be able to join. These criteria are checked using your medical records, what you tell us, or by the study doctor.

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. Have you tried and not succeeded at losing weight with diets before?
  3. Is your BMI 30 or higher, OR is it 27 or higher AND you have a weight-related health issue?
  4. Do you NOT have type 1 or type 2 diabetes?
  5. Have you NOT used other weight-loss medications in the last 6 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for about 18 months (1 year and 6 months). During this time, you'll receive either the study medicine, Cagrilintide, or a placebo, which will be decided by chance, much like flipping a coin. You'll have regular visits with the study team and doctors. They will check your health, measure your weight, and ask about any changes you notice or any side effects. All possible side effects will be carefully monitored throughout your time in the study.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of trying a new medicine that could help with weight loss before it's widely available. However, there's no guarantee that you will receive the active medicine or that it will work for you. Like all medicines, Cagrilintide may have side effects, which the study team will monitor closely. You will be told about all known potential side effects before you decide to join. It's important to know that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Diablo Clinical Research, Inc.
    Verified postcode
    Walnut Creek, United States
  • Univ of Colorado at Denver
    Verified postcode
    Aurora, United States
  • Florida Inst For Clin Res LLC
    Verified postcode
    Orlando, United States
  • Oviedo Medical Research, LLC
    Verified postcode
    Oviedo, United States
  • Walgreens - Store 11760
    Verified postcode
    Oak Park, United States
  • Midwest Inst For Clin Res
    Verified postcode
    Indianapolis, United States
  • StudyMetrix Research LLC
    Verified postcode
    City of Saint Peters, United States
  • PharmQuest Life Sciences LLC
    Verified postcode
    Greensboro, United States
  • Selma Medical Associates
    Verified postcode
    Winchester, United States
  • CIPREC Pueyrredon
    Verified postcode
    Buenos Aires, Argentina
  • CEDIC Centro de Investigación Clínica
    Unverified
    CABA, Argentina
  • Sydney Cardiometabolic Centre
    Verified postcode
    Liverpool, Australia

Common questions

What is Cagrilintide?

Cagrilintide is a new medicine being tested to see if it helps people lose weight if they are overweight or have obesity.

What is a placebo?

A placebo is a dummy treatment that looks like the actual medicine but doesn't have any active ingredients. It helps doctors compare the effects of the new medicine.

How long does the study last?

If you join, the study will last for about 1 year and 6 months for each person.

Will I definitely get the new medicine?

No, you'll be put into one of two groups by chance. About two out of three people will get Cagrilintide, and one out of three will get the placebo.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.

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.