Active not recruitingPHASE3INTERVENTIONAL

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

This study aims to find out how well a new medicine, CagriSema, helps people who are overweight or obese lose weight. It's split into two parts: a main study and an extension. In the main study, participants will randomly receive CagriSema, two other specific medicines (cagrilintide or semaglutide), or a dummy (placebo) medicine. All treatments are given as a weekly injection, typically in the stomach, thigh, or arm. The main study lasts about 18 months, focusing on weight loss. The extension study, lasting two years for some participants, will see what happens to their weight and health after they stop the study medicine. This helps researchers understand the long-term effects of stopping treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

3,400

Start

01 Nov 2022

Estimated completion

19 Oct 2026

Obesity

What is this study about?

This research study is looking into a new medicine called CagriSema, and how well it helps people who are overweight or have obesity to lose weight. Being overweight can sometimes lead to other health problems, so finding effective ways to manage weight is important for many people.

The study has two main parts. The first part, the main study, will compare CagriSema to two existing medicines (cagrilintide and semaglutide) and also to a 'dummy' medicine that has no active ingredients, called a placebo. This comparison helps the researchers understand if CagriSema is more effective than these other options. The type of medicine you receive is chosen by chance, like flipping a coin, so it's fair for everyone.

The second part, called the extension study, involves some participants from the main study. If you continue into this part, you won't be taking any study medicine. Instead, the researchers want to see what happens to your weight and any related health conditions after you've stopped the treatment. This helps them understand the longer-term effects and how people's bodies respond once they are no longer taking the study drug.

Key takeaways

This study evaluates a new weight-loss medicine, CagriSema.
It involves weekly injections of CagriSema, other medicines, or a dummy treatment.
The main study focuses on weight loss over 1.5 years.
An extension study (2 years) tracks body weight and health after treatment stops.
Eligibility includes being 18+ with a certain BMI, or a lower BMI with weight-related health issues.
You cannot participate if you have diabetes or very high blood sugar levels.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. Your Body Mass Index (BMI) also needs to be 30 or higher. BMI is a measure that uses your height and weight to see if you are a healthy weight.

However, if your BMI is 27 or higher, you might still be able to join if you also have at least one health condition linked to being overweight. Examples of these conditions include high blood pressure, unhealthy cholesterol levels, sleep apnoea (where your breathing stops and starts while you sleep), or heart disease.

There are also a few reasons why you couldn't take part. For example, if you have certain levels of sugars in your blood (measured by something called HbA1c) that are too high, or if you have ever been diagnosed with type 1 or type 2 diabetes, you would not be able to join 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?
Is your Body Mass Index (BMI) 30 or higher?
If your BMI is 27 or higher, do you also have a weight-related health problem like high blood pressure or sleep apnoea?
Do you currently have type 1 or type 2 diabetes?
Have you had recent blood tests showing very high blood sugar levels (HbA1c of 6.5% or more)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for about three and a half years in total. The first part, the 'main study', will last for about one and a half years. During this time, you will receive one of four study medicines (CagriSema, cagrilintide, semaglutide, or a dummy medicine). The medicine is given as an injection once a week using a very thin needle, usually into your stomach, thigh, or upper arm.

After the main study, some participants will be asked to continue into the 'extension study', which lasts for another two years. You'll be told by the study staff if you are selected for this. If you continue, you won't receive any more study medicine. Instead, the researchers will check your weight and how any weight-related health conditions are doing, to see what happens after treatment stops.

Throughout both parts of the study, you'll have regular visits to the clinic for check-ups and assessments. These visits will involve health checks and possibly blood tests to monitor your progress and ensure your safety. The specific number of visits would be explained in detail if you are considering joining.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medicine that might help you lose weight, or receiving close medical care and monitoring. However, like all medicines, the study treatments may have side effects, which the study team will explain in full detail. There's also a chance you might receive the dummy medicine which has no active drug. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (254)

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
Velocity Clin Res Los Angeles
Verified postcode
Los Angeles, United States
Velocity Clin Res Wstlke
Verified postcode
Los Angeles, United States
Univ of Colorado at Denver
Verified postcode
Aurora, United States
OptumCare Clinical Trials LLC
Verified postcode
Golden, United States
Northeast Research Institute
Verified postcode
Fleming Island, United States
South Broward Research LLC
Verified postcode
Miramar, United States
Clinical Neuroscience Solution
Verified postcode
Orlando, United States
Florida Inst For Clin Res
Verified postcode
Orlando, United States
Clinical Trial Res Assoc,Inc
Verified postcode
Plantation, United States
Hope Clin Res & Wellness
Verified postcode
Conyers, United States
East West Med Res Inst
Verified postcode
Honolulu, United States

Common questions

What is CagriSema?

CagriSema is a new medicine being tested to see if it helps people who are overweight lose weight. The study will compare it to other medicines and a dummy treatment.

How will I take the medicine?

The medicine is given as an injection once a week. It's a small injection with a thin needle, typically into your stomach, thigh, or upper arm.

What is a 'dummy medicine'?

A 'dummy medicine' (or placebo) looks just like the study medicine but doesn't contain any active drug. It helps researchers compare if the real medicine is actually working.

How long will the study last?

The main part of the study lasts about one and a half years. If you join the extension study, it will be another two years, making it about three and a half years in total.

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

No, you won't know which treatment you are receiving. This is common in research studies and helps to keep the results fair and unbiased.