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A study testing cagrilintide and semaglutide compared to placebo in people with type 2 diabetes not well controlled by diet and exercise

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with type 2 diabetes, which is a condition where the body does not properly control blood sugar levels. The study will test a treatment called CagriSema, which is a combination of two medications: cagrilintide and semaglutide. These medications are given together as an injection under the skin. Different doses of this combination treatment will be compared to placebo to see how well they work.

The purpose of this study is to find out if CagriSema can lower blood sugar levels and reduce body weight better than placebo in people with type 2 diabetes who are managing their condition with diet and exercise but still have blood sugar levels that are too high. The study will measure changes in a blood test called HbA1c, which shows average blood sugar levels over time, and will also look at changes in body weight and other health measurements.

People taking part in this study will receive either CagriSema at different dose levels or placebo once a week for 40 weeks. The treatment is given as an injection under the skin. During the study, regular visits will be scheduled to check blood sugar levels, body weight, blood pressure, and other health markers. Blood tests will be done to measure various substances in the blood, and questionnaires will be used to understand how participants feel about their energy levels and satisfaction with treatment. After the treatment period ends, there will be a follow-up period of 12 weeks to continue monitoring participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period begins
The treatment period starts at week 0, which is considered the baseline.
At this point, measurements will be taken including HbA1c (a blood test that shows average blood sugar levels over the past 2-3 months), body weight, waist circumference, blood pressure, and blood samples for various tests.
These baseline measurements will be used to compare changes throughout the study.
Step 2
Receiving study medication
You will receive one of the following treatments as an injection under the skin (subcutaneous injection):
Option 1: cagrilintide combined with semaglutide at a dose of 2.4 mg/2.4 mg, administered once weekly.
Option 2: cagrilintide combined with semaglutide at a dose of 1.0 mg/1.0 mg, administered once weekly.
Option 3: placebo (an inactive substance with no medication), administered once weekly.
The medication will be given as a solution for injection.
You will continue receiving the assigned treatment once weekly for 40 weeks.
Step 3
Ongoing monitoring during treatment
Throughout the 40-week treatment period, various measurements and tests will be performed at scheduled visits.
These will include monitoring of blood sugar levels, body weight, waist circumference, blood pressure, and blood tests.
Blood tests will measure fasting plasma glucose (blood sugar level after not eating), cholesterol levels (including total cholesterol, HDL, LDL, VLDL, triglycerides, and free fatty acids), and hsCRP (a marker of inflammation in the body).
Additional tests may include an OGTT (oral glucose tolerance test, which measures how the body processes sugar after drinking a glucose solution).
Questionnaires will be completed to assess quality of life, energy levels, and satisfaction with diabetes treatment.
Any side effects or health changes will be recorded throughout this period.
Step 4
End of treatment
At week 40, the treatment period ends.
Final measurements will be taken, including HbA1c, body weight, waist circumference, blood pressure, and various blood tests.
The results at week 40 will be compared to the baseline measurements from week 0 to determine the effects of the treatment.
Assessments will include whether blood sugar targets have been achieved (HbA1c less than 7.0% or 6.5%) and the amount of weight reduction.
Step 5
Follow-up period after treatment
After completing the 40-week treatment period, you will enter a follow-up period lasting 12 weeks.
During this time, you will no longer receive the study medication.
Monitoring will continue for an additional 7 weeks to track any side effects or health changes.
At the end of the follow-up period (12 weeks after treatment ends), an assessment will be made to determine if diabetes remission has occurred (defined as HbA1c below 6.5% without taking diabetes medication).
The total duration from the start of treatment to the end of follow-up is approximately 52 weeks (40 weeks of treatment plus 12 weeks of follow-up).

Who can join the trial?

5 criteria

You can be male or female
You must be 18 years old or older at the time you sign the consent form
You must have been diagnosed with type 2 diabetes, which is a condition where your body does not use insulin properly to control blood sugar levels, at least 30 days before the first study visit
Your HbA1c level must be between 7.0% and 9.5%. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months
Your BMI must be 23 or higher. BMI stands for Body Mass Index, which is a measure that uses your height and weight to determine if you are in a healthy weight range

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why someone cannot join a study, such as having certain other medical conditions, taking specific medications, or having particular test results that would make participation unsafe or affect the study results
Without detailed exclusion criteria information, it is not possible to list the specific reasons why a patient would not be able to participate in this study

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Verified sites

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Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Centrum Medyczne Medyk Sp. z o.o.
Verified
Rzeszow, Poland
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

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Investigated drugs

Cagrilintide
is a medication being tested in this clinical trial. It is given as an injection under the skin once a week. In this study, cagrilintide is being used in combination with another diabetes medication to help control blood sugar levels in people with type 2 diabetes who have not achieved good blood sugar control through diet and exercise alone.
Semaglutide
is a medication used to treat type 2 diabetes. It is given as an injection under the skin once a week. In this trial, semaglutide is being used together with cagrilintide to help lower blood sugar levels in people whose diabetes is not well controlled by diet and exercise alone.
CagriSema
is a combination treatment that includes both cagrilintide and semaglutide given together. This combined medication is being tested to see if it works better than placebo at lowering blood sugar levels in people with type 2 diabetes who have not been able to control their blood sugar well enough through diet and exercise.

What is already known about the treatment

CagriSema – CagriSema is an injectable medication given under the skin once a week that combines two active substances: cagrilintide and semaglutide. It is currently being studied in clinical trials for the treatment of type 2 diabetes in patients who have not achieved adequate blood sugar control through diet and exercise alone. The medication works by mimicking natural hormones in the body that help regulate blood sugar levels, reduce appetite, and slow down digestion. CagriSema belongs to a class of diabetes medications that help the pancreas release insulin when blood sugar is high and decrease the amount of sugar produced by the liver.

Investigated diseases

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin, which is a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. As the condition progresses, blood sugar levels remain elevated, which can affect various organs and systems in the body over time. People with type 2 diabetes often experience symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. The disease typically develops gradually, often over several years, and may go unnoticed in its early stages. Poor control of blood glucose levels can lead to complications affecting the eyes, kidneys, nerves, heart, and blood vessels.