Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg once weekly versus placebo in participants with type 2 diabetes inadequately controlled on diet and exercise.

This research study is for adults with type 2 diabetes whose blood sugar isn't well controlled by diet and exercise alone. It's investigating a new combination medicine, CagriSema, which contains two existing drugs, cagrilintide and semaglutide. Participants will receive either one of two doses of this combination medicine or a dummy treatment (placebo). The main goals are to see how much the medicine lowers blood sugar levels (measured by HbA1c) and helps with weight loss over 40 weeks. Researchers will also look at other health markers like blood pressure and cholesterol. The study aims to find out if this combination is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novo Nordisk A/S

Enrolment target

Start

10 Apr 2024

Type 2 diabetes

What is this study about?

This study is a Phase 3 clinical trial, which means it's a large, important study designed to confirm how well a new treatment works and if it's safe before it can be made widely available. The treatment being tested is a combination of two medicines, cagrilintide and semaglutide, called CagriSema. This combination is given as an injection under the skin once a week. The study is specifically for people living with type 2 diabetes who are finding it hard to control their blood sugar levels with just diet and exercise.

The main thing the researchers want to find out is whether CagriSema can significantly lower blood sugar levels, measured by a test called HbA1c, compared to a dummy treatment (placebo). They will measure this over a period of 40 weeks. HbA1c gives an average picture of blood sugar control over the past 2-3 months.

Beyond blood sugar, the study also aims to understand CagriSema's effects on other important health aspects. This includes looking at how much weight people might lose, and changes in blood pressure, cholesterol, and overall energy levels. By comparing different doses of the combination medicine to a placebo, the researchers can get a clear idea of its potential benefits and any side effects.

Key takeaways

Tests a new combination drug (CagriSema) for type 2 diabetes.
Aims to improve blood sugar control and promote weight loss.
Participants receive weekly injections of either the drug or a placebo.
Study lasts 40 weeks for treatment, plus 12 weeks follow-up.
Open to adults 18+ with type 2 diabetes not controlled by diet/exercise.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have been diagnosed with type 2 diabetes. Essential for participation is that your diabetes isn't fully under control with just healthy eating and regular physical activity.

The study is open to both men and women. There might be other specific health requirements or conditions that would mean you can't join, which a study doctor would discuss with you.

Since this is for uncontrolled type 2 diabetes despite diet and exercise, if you are already on other strong diabetes medications, or if your diabetes is very well controlled, this study might not be suitable for you.

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?
Are your blood sugar levels not fully controlled, even with diet and exercise?
Are you willing to have weekly injections?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of several groups. You will either receive a specific dose of the CagriSema combination medicine, or a placebo (a dummy treatment that looks like the active medicine but contains no active ingredients). This will be given as an injection under the skin once a week for 40 weeks.

Throughout the 40 weeks, you will have regular visits to the study clinic for health checks. These visits will involve blood tests to measure your blood sugar (HbA1c, fasting glucose), cholesterol, and other markers, as well as checking your weight, waist measurement, and blood pressure. You might also be asked to complete questionnaires about your energy levels. After the 40 weeks of treatment, there will be a follow-up period of 12 weeks during which you will have further check-ups to see how you are doing.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your blood sugar control and weight. However, there's a chance you might receive the placebo and not the active drug. Potential risks include side effects from the medication, which would be explained in detail before you decide to join. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
Hungary
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Unverified
Poland

Common questions

What is CagriSema?

CagriSema is a new combination medicine being tested, which includes two drugs, cagrilintide and semaglutide, given together.

How is the medicine given?

The medicine is given as an injection under the skin, once a week.

How long will the study last?

The treatment part of the study lasts for 40 weeks, followed by an additional 12 weeks of follow-up.

Will I know if I'm getting the active medicine or a placebo?

No, you won't know directly. This is to ensure the study results are as accurate as possible.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months.