Active not recruitingPHASE3INTERVENTIONAL

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

This research is investigating a new medicine, cagrilintide, for adults who are living with overweight or obesity and also have type 2 diabetes. The main goal is to find out how much this medicine helps people lose weight. Cagrilintide is still being tested and is not yet available from doctors. Participants in the study will be given either cagrilintide or a placebo (a dummy medicine that looks the same but has no active ingredient). The decision about which treatment you get is made by chance, with a higher chance of receiving cagrilintide. Like all medicines, this study medicine may have side effects. The study will last for about 18 months for each person.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

330

Start

05 Nov 2025

Estimated completion

30 Jun 2027

Overweight Obesity Type 2 Diabetes

What is this study about?

This study is particularly interested in helping people who are living with overweight or obesity and also have type 2 diabetes. These conditions can have a significant impact on health and daily life, and finding new ways to manage them is important. Researchers are testing a new investigational medicine called cagrilintide to see if it can help people in this group lose weight.

Cagrilintide is still in the testing phase, which means it hasn't been approved for use by doctors yet. Clinical trials like this one are a crucial step in understanding if new medicines are safe and effective. By taking part, you would be contributing valuable information that could help others in the future.

Participants will be randomly assigned to receive either cagrilintide or a placebo. A placebo looks exactly like the study medicine but contains no active drug. This helps researchers fairly compare the effects of the new medicine. You'll have a two-thirds chance of receiving cagrilintide and a one-third chance of receiving the placebo. The study will last for around 18 months for each person involved.

Key takeaways

New medicine for weight loss and type 2 diabetes.
Chance of receiving active medicine or a dummy medicine.
Study lasts about 18 months.
Regular health checks and monitoring required.
Participation is voluntary, you can leave at any time.
Helps researchers understand new treatments.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) and have type 2 diabetes that was diagnosed at least six months ago. You should also have a body mass index (BMI) of 27 or higher. On top of this, you should have tried to lose weight through diet at least once before, without success.

When it comes to medications, you can be receiving lifestyle advice for your diabetes, or taking certain diabetes medicines (like metformin, SGLT2i, or DPP-4i) in a stable dose for at least three months. In some cases, people taking an older type of GLP-1 medicine for over a year, or a stable dose of basal insulin for at least three months, may also be able to join.

However, you can't join if you've recently used (in the last six months) any other medicines specifically for weight loss, or if you've recently used most types of GLP-1 medicines. You also can't have taken similar 'amylin-based' medicines before. If you're unsure about any of these points, your doctor can help clarify.

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 type 2 diabetes diagnosed at least six months ago?
Is your Body Mass Index (BMI) 27 or higher?
Have you tried to lose weight with diet before, unsuccessfully?
Have you *not* used other weight loss medicines in the last six months (with some exceptions for certain diabetes treatments)?
Are you able to agree to the study rules and procedures?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 1 year and 6 months (18 months). During this time, you'll have regular visits to the study clinic where you'll receive your assigned study medication (cagrilintide or placebo). These visits will involve various health checks, such as measuring your weight, blood pressure, and taking blood samples to monitor your health and how the medicine is affecting you. You'll also be asked about any side effects you might experience. The exact number of visits and tests will be explained in detail by the study team, but they are all part of making sure the study is safely carried out and gathers the necessary information.

Potential risks and benefits

Taking part in a clinical study could potentially offer the benefit of receiving a new investigational medicine that might help with weight loss and managing your type 2 diabetes. However, like all medicines, cagrilintide may have side effects, and some are not yet fully known. Also, there's a chance you might receive the placebo and not the active medicine. The study team will monitor you closely for any side effects and will explain them all in detail. Remember, your participation is voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (67)

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

Univ of Alabama_Birmingham
Verified postcode
Birmingham, United States
Chambliss Clinical Trials, LLC
Verified postcode
Montgomery, United States
Elite Clinical Network - Tucson
Verified postcode
Tucson, United States
Scripps Whittier Diabetes Inst
Verified postcode
La Jolla, United States
Clinical Trials Research
Verified postcode
Lincoln, United States
Pacific Clinical Studies
Verified postcode
Los Alamitos, United States
Walgreens - Store 4442
Verified postcode
Kissimmee, United States
Optimal Research Sites
Verified postcode
Orange City, United States
Center for Diab,Obes & Metab
Verified postcode
Pembroke Pines, United States
Palm Beach Research Center
Verified postcode
West Palm Beach, United States
East West Med Res Inst
Verified postcode
Honolulu, United States
MediSphere Medical RC
Verified postcode
Evansville, United States

Common questions

What is cagrilintide?

Cagrilintide is a new medicine being tested to see if it helps with weight loss in people with overweight or obesity and type 2 diabetes. It's not yet available from doctors.

Will I definitely get the new medicine?

No. You have a two-thirds chance of getting cagrilintide and a one-third chance of getting a placebo (a dummy medicine).

How long will the study last if I join?

The study will last for about 1 year and 6 months (18 months) for each person who takes part.

What does 'placebo' mean?

A placebo is a dummy treatment that looks exactly like the study medicine but contains no active drug. This helps researchers compare the real effects of the new medicine.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.