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A study testing cagrilintide and semaglutide combination for kidney damage in people with chronic kidney disease and type 2 diabetes who are overweight or obese

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What is this trial about?

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

This study is looking at chronic kidney disease and type 2 diabetes in people who are living with overweight or obesity. Chronic kidney disease is a condition where the kidneys gradually lose their ability to work properly over time. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will test a combination treatment called CagriSema, which contains two medicines: cagrilintide and semaglutide. These medicines are given together as an injection under the skin once a week. The study will compare this combination treatment to cagrilintide alone, semaglutide alone, and placebo to see which works best.

The purpose of this study is to find out if CagriSema can improve markers that show how chronic kidney disease is progressing in people with type 2 diabetes who are living with overweight or obesity. Participants may also be taking other medicines during the study, such as enalapril maleate, dapagliflozin propanediol, or finerenone, which are used to help protect the kidneys and manage related conditions. The study will measure changes in urine protein levels, kidney function, body weight, waist size, blood sugar control, and blood pressure. It will also track any side effects or health problems that occur during treatment.

During the study, participants will receive their assigned treatment for up to 35 weeks. They will attend regular visits where measurements will be taken and blood and urine samples will be collected to check how well the treatment is working and to monitor safety. The study team will look at changes from the start of the study to the end of treatment to understand the effects of each treatment option.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period
During this clinical trial, you will receive one of four possible treatments. The treatment assigned to you will be determined randomly, similar to flipping a coin.
The four possible treatment options are: cagrilintide combined with semaglutide, semaglutide alone, cagrilintide alone, or placebo (an inactive substance that looks like the medication but contains no active ingredients).
All medications in this trial are given as injections under the skin (subcutaneous injections), except for some additional medications that are taken by mouth.
You will receive your assigned treatment once weekly throughout the study period.
The treatment will continue until the end of the study, which is estimated to last until November 2025.
Step 2
Medication dosing
If you are assigned to receive cagrilintide combined with semaglutide, you will receive a dose of 2.4 mg of cagrilintide and 2.4 mg of semaglutide in a single injection once weekly.
If you are assigned to receive semaglutide alone, you will receive a dose of 2.4 mg once weekly.
If you are assigned to receive cagrilintide alone, you will receive a dose of 2.4 mg once weekly.
If you are assigned to receive placebo, you will receive an injection that contains no active medication once weekly.
Some participants may also receive additional medications by mouth, including finerenone, dapagliflozin, or enalapril, depending on your specific medical needs.
Step 3
Background medication requirements
Throughout the trial, you must continue taking your current medication for blood pressure control. This medication should be either an ACE inhibitor (a type of blood pressure medication that helps protect the kidneys) or an ARB (angiotensin II receptor blocker, another type of blood pressure medication).
You should be taking the maximum dose recommended on the medication label or the highest dose you can tolerate.
The dose of this blood pressure medication must remain stable and unchanged during the trial.
Step 4
Regular monitoring visits
You will attend regular visits at the study site throughout the trial period.
During these visits, measurements will be taken to assess how the treatment is affecting your condition.
Your kidney function will be monitored through blood tests that measure eGFR (estimated glomerular filtration rate, which indicates how well your kidneys are filtering waste from your blood). This will be measured using both creatinine and cystatin C levels in your blood.
Your urine albumin-to-creatinine ratio (UACR) will be checked. This test measures the amount of protein in your urine, which is an indicator of kidney damage.
Your body weight will be measured at each visit to track changes during the treatment.
Your waist circumference will be measured.
Your blood pressure will be checked, including both systolic (the higher number) and diastolic (the lower number) readings.
Blood tests will measure your HbA1c (glycated hemoglobin), which shows your average blood sugar levels over the past two to three months.
Your blood glucose (blood sugar) levels will be monitored to check for episodes of low blood sugar (hypoglycemia).
Step 5
Safety monitoring
Throughout the trial, you will be monitored for any adverse events, which are unwanted or harmful reactions that may occur during treatment.
Any serious adverse events, which are more severe medical problems, will be carefully recorded and assessed.
Special attention will be given to episodes of low blood sugar. Clinically significant low blood sugar is defined as a blood glucose level below 3.0 mmol/L (54 mg/dL) confirmed by a blood glucose meter.
Severe low blood sugar episodes will also be monitored. These are situations where low blood sugar causes confusion or impairment serious enough that you need help from another person to recover.
Step 6
End of treatment
At the end of the treatment period, final measurements will be taken to compare with your initial measurements from the beginning of the trial.
These final assessments will include all the same measurements taken during your regular monitoring visits, such as kidney function tests, body weight, waist circumference, blood pressure, and blood sugar control.
The information collected throughout the trial will help determine whether the treatment had an effect on kidney disease progression and other health markers.

Who can join the trial?

8 criteria

You must be 18 years of age 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 180 days (about 6 months) before the screening visit
Your BMI (body mass index, which is a measure of body fat based on your height and weight) must be 27.0 or higher at the screening visit
Your HbA1c (a blood test that shows your average blood sugar level over the past 2 to 3 months) must be 10.5% or lower at the screening visit
You must have reduced kidney function shown by a blood test called eGFR (estimated glomerular filtration rate, which measures how well your kidneys filter waste from your blood) that is between 15 and less than 90
You must have albuminuria, which means protein in your urine, with a UACR (urine albumin-to-creatinine ratio, a test that measures the amount of protein in your urine) between 100 and less than 5000
You must be taking the highest recommended or highest dose you can tolerate of a medication called an ACE inhibitor (angiotensin converting enzyme inhibitor) or ARB (angiotensin II receptor blocker), which are medications that help protect your kidneys and control blood pressure, unless your doctor believes you should not take these medications. You must have been on the same dose for at least 30 days before screening
This study includes both male and female participants

Who cannot join the trial?

5 criteria

The source data does not provide specific exclusion criteria (reasons why you cannot participate) for this clinical trial
If you are interested in this study, you will need to discuss with the research team what conditions or situations might prevent you from taking part
Generally, clinical trials have rules about who can join to make sure the study is safe and the results are reliable
These rules may include things like other medical conditions you have, medicines you are taking, or recent treatments you have received
The research team will review your complete medical history to determine if you are able to participate safely

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Verified sites

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Athens Medical Center S.A.
Thessaloniki, Greece
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Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
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M2m Med. Sp. z o.o.
Chorzow, Poland
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Investigated drugs

Cagrilintide
is a medication being tested to help people with type 2 diabetes who are overweight or obese. It works by helping to control blood sugar levels and may also help with weight loss. In this trial, it is being studied to see if it can help improve kidney function in people with chronic kidney disease.
Semaglutide
is a medication used to treat type 2 diabetes and help with weight management. It works by helping the body produce more insulin when blood sugar is high and by reducing appetite. In this trial, it is being tested to see if it can help improve kidney function in people with chronic kidney disease and type 2 diabetes who are overweight or obese.
CagriSema
is a combination medication that contains both cagrilintide and semaglutide together in one treatment. This combination is being tested to see if using both medications together works better than using either medication alone for improving kidney function in people with type 2 diabetes and chronic kidney disease who are overweight or obese.

What is already known about the treatment

Cagrilintide
Cagrilintide is an investigational medication given as an injection under the skin, typically once weekly, that is being studied for the treatment of chronic kidney disease in people with type 2 diabetes who are overweight or obese. This substance works at the molecular level by mimicking a natural hormone called amylin, which helps regulate blood sugar levels and reduces appetite by slowing down stomach emptying and signaling to the brain that you feel full. Cagrilintide belongs to a class of medications called amylin analogues, which are designed to help control both blood sugar and body weight. In this clinical trial, it is being tested alone and in combination with another medication to see if it can slow down the progression of kidney disease.
Semaglutide
Semaglutide is a medication administered as an injection under the skin once weekly that is currently approved for treating type 2 diabetes and obesity, and is being studied in this trial for its effects on chronic kidney disease in people with type 2 diabetes who are overweight or obese. This drug works by mimicking a natural hormone called GLP-1, which stimulates insulin release when blood sugar is high, reduces appetite by acting on brain centers that control hunger, and slows down how quickly food leaves the stomach. Semaglutide belongs to a class of medications known as GLP-1 receptor agonists, which are widely used to help manage blood sugar levels and promote weight loss. In this clinical trial, it is being tested both alone and in combination with cagrilintide to evaluate whether it can help slow the worsening of kidney disease.

Investigated diseases

Chronic Kidney Disease
Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste products and excess fluids from the blood. The disease develops slowly over months or years, often without noticeable symptoms in the early stages. As the condition progresses, waste products build up in the body, which can affect other organs and bodily functions. The kidneys become less effective at maintaining the balance of minerals and fluids in the body. In advanced stages, patients may experience swelling, fatigue, and changes in urination patterns. The disease is typically classified into five stages based on how well the kidneys are functioning.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects how the body processes blood sugar, also known as glucose. In this disease, the body either does not produce enough insulin or the cells become resistant to insulin's effects, leading to elevated blood sugar levels. The condition usually develops gradually, often over several years, and may not cause noticeable symptoms initially. Over time, high blood sugar levels can damage blood vessels and nerves throughout the body. Common symptoms that may appear include increased thirst, frequent urination, fatigue, and blurred vision. Without proper management, the disease can lead to complications affecting the eyes, kidneys, heart, and other organs.
Overweight
Overweight is a condition characterized by excess body weight in relation to height, typically measured using body mass index. It occurs when a person consistently consumes more calories than their body uses for energy, leading to the accumulation of body fat. The condition develops gradually as excess weight accumulates over time. Being overweight can affect physical mobility and put additional strain on joints and the cardiovascular system. It often progresses without obvious symptoms beyond the visible increase in body size. The condition can contribute to the development of other health issues affecting metabolism and organ function.
Obesity
Obesity is a medical condition characterized by excessive accumulation of body fat that may impair health. It develops when energy intake from food and drinks exceeds energy expenditure over a prolonged period. The condition typically progresses gradually, with body fat accumulating in various parts of the body. As obesity advances, it can affect multiple body systems and reduce physical function and mobility. People with obesity may experience breathlessness, increased sweating, and difficulty performing everyday activities. The excess body weight places additional stress on joints, the heart, and other organs.