Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c. (CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) once-weekly in participants with overweight or obesity

This project is a phase 3 clinical trial, which means it’s one of the final stages of testing a new medicine before it might become widely available. The study is investigating a new treatment called CagriSema, which is a combination of two existing medicines, cagrilintide and semaglutide. It's designed for people who are overweight or living with obesity. Participants will receive weekly injections of CagriSema or a dummy injection (placebo). The main goal is to find out how much weight people lose and if the treatment is safe. Researchers will also look at how it affects waist size, blood pressure, and cholesterol levels. If successful, this new medication could offer another option for managing weight.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

100

Start

26 Jun 2024

Obesity

What is this study about?

This research study is looking at a new medicine called CagriSema, which is a combination of two already known medications. It’s being tested in adults who are overweight or have obesity. The main purpose of this study is to see how well CagriSema helps people lose weight and if it's safe for them to use. This new medicine is given as a weekly injection under the skin.

The study is in a late stage of testing, called Phase 3, which means it's a very important step before a new medicine can be approved for wider use. Researchers will compare people taking CagriSema to those taking a 'dummy' injection, called a placebo. This helps them understand the true effects of the new medicine.

They'll be carefully measuring how much weight people lose, checking if they achieve certain weight loss goals (like losing 5%, 10%, 15%, or 20% of their body weight). They will also be looking at other important health markers like changes in waist size, blood pressure, and different types of fats in the blood, such as cholesterol and triglycerides. All this information helps doctors understand the full effects of the treatment.

Key takeaways

Tests a new weekly injection called CagriSema for weight management.
Aims to see how much weight people lose and if the medicine is safe.
Looks at other health benefits like changes in blood pressure and cholesterol.
Open to adults aged 18 and over who are overweight or have obesity.
Patients will either receive the new medicine or a dummy injection (placebo).

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must be either overweight or have obesity to be considered for participation. The researchers will have specific criteria based on your Body Mass Index (BMI) to determine this, but generally, it means your weight is higher than what's considered healthy for your height.

There will also be other health requirements that the study doctors will check to make sure the treatment is suitable and safe for you. These will be discussed in detail if you express interest.

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?
Are you currently overweight or living with obesity?
Are you able to attend regular appointments for the study?
Are you comfortable with receiving weekly injections?
Are you not currently pregnant or planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new combination medicine (CagriSema) or a dummy injection (placebo) once a week. All doses will be given as an injection under the skin. Throughout the study, you'll have regular visits to the clinic, where the study team will monitor your health closely. This will involve assessments like measuring your body weight, waist circumference, and blood pressure. You will also have blood tests to check things like cholesterol and other fat levels.

The total duration of your participation in the study, including all treatments and follow-up visits, will be explained in detail by the study team. You will be given a clear schedule of visits and what to expect at each appointment.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving a new medicine that might help with weight loss, or contribute to scientific knowledge that helps others. However, like all medicines, CagriSema may have side effects, and some people will receive placebo, meaning they won't get any active treatment. The study team will explain all known or potential risks in detail, and you will have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
France
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Unverified
Germany

Common questions

What is CagriSema?

CagriSema is a new medicine being tested, which combines two active medications, cagrilintide and semaglutide, into one weekly injection.

Why is this study important?

This study is important because it could lead to a new treatment option for people living with overweight or obesity, helping them achieve significant weight loss.

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

No, in this type of study, neither you nor the study team will know whether you are receiving the active medicine or the placebo. This helps ensure unbiased results.

How long does the study last?

The full duration of your participation, including all treatments and follow-up, will be explained by the research team when you inquire about the study.

What if I decide I don't want to continue?

You can leave the study at any time, for any reason, without having to explain why, and it won't affect your future medical care.