A study testing cagrilintide for weight loss in people with overweight or obesity and type 2 diabetes

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What is this study about?

This study involves people who have overweight or obesity and also have type 2 diabetes, which is a condition where the body does not use insulin properly, leading to high blood sugar levels. The treatment being tested is cagrilintide, which is given as an injection under the skin once a week. Some people in the study will receive cagrilintide while others will receive placebo. The purpose of the study is to see if cagrilintide helps people lose more body weight compared to placebo when combined with lifestyle counseling about diet and physical activity.

During the study, participants will receive either cagrilintide at different dose levels or placebo for a treatment period of up to 64 weeks. All participants will also receive guidance on lifestyle changes to support weight management. The study will measure changes in body weight and track how many people achieve weight loss of at least 5%, 10%, or 15% of their starting weight. Other measurements will include changes in waist size, blood sugar control measured by HbA1c (a test that shows average blood sugar levels over time), blood pressure, and various blood fats such as cholesterol and triglycerides.

The study will also assess quality of life using questionnaires that ask about physical function and overall well-being, and will monitor any side effects or health problems that occur during treatment. Safety will be carefully tracked, including any episodes of low blood sugar, which can happen when blood sugar drops below normal levels. Participants may continue taking their usual diabetes medications during the study if they have been on a stable dose for a certain period before joining.

1 Initial treatment assignment

After joining the study, you will be assigned to receive either cagrilintide or placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

The medication will be provided as a solution for injection that is administered under the skin (subcutaneous injection).

You will not know whether you are receiving cagrilintide or placebo during the study.

2 Treatment administration

You will receive injections once weekly throughout the treatment period.

The injections will be given under the skin (subcutaneous route).

If you are assigned to the active treatment group, you will receive cagrilintide at a specific dose determined by the study protocol.

3 Lifestyle intervention counseling

Throughout the study, you will receive lifestyle intervention counseling in addition to the medication.

This counseling is designed to support weight management through guidance on diet and physical activity.

4 Continuation of diabetes medications

If you are currently taking medications for type 2 diabetes, you will continue taking them as prescribed during the study.

Your diabetes treatment may include oral medications such as metformin or other antidiabetic drugs, and in some cases, insulin injections.

The dose and frequency of your diabetes medications will remain stable throughout the study.

5 Body weight monitoring

Your body weight will be measured regularly throughout the study.

The study will track changes in your weight to determine the effectiveness of the treatment.

Measurements will also include your waist circumference.

6 Blood sugar monitoring

Your blood sugar levels will be monitored during the study.

This includes measurements of fasting plasma glucose (blood sugar level after not eating overnight) and HbA1c (a measure of average blood sugar levels over the past 2 to 3 months).

You will be monitored for episodes of hypoglycemia (low blood sugar), which can occur when blood sugar drops below normal levels.

7 Blood pressure monitoring

Your blood pressure will be measured at regular intervals during the study.

Both the upper number (systolic) and lower number (diastolic) of your blood pressure will be recorded.

8 Blood tests

Blood samples will be collected to measure various substances in your blood.

These tests will measure cholesterol levels (including total cholesterol, HDL or ‘good’ cholesterol, LDL or ‘bad’ cholesterol, and other types).

Additional tests will measure triglycerides (a type of fat in the blood), insulin (a hormone that regulates blood sugar), and hsCRP (a marker of inflammation in the body).

9 Quality of life assessments

You will be asked to complete questionnaires about how your weight affects your quality of life.

These questionnaires will assess your physical function and overall well-being.

The assessments will help determine how the treatment affects your daily activities and general health.

10 Safety monitoring

Throughout the study, you will be monitored for any adverse events, which are unwanted or harmful effects that may occur during treatment.

Any serious health problems that occur during the study will be recorded and evaluated.

Special attention will be given to episodes of low blood sugar, particularly those requiring assistance from another person.

11 Study completion

The study is expected to continue until July 2027.

You will attend regular study visits throughout the treatment period.

Final assessments will be conducted at the end of your participation to evaluate the overall effects of the treatment.

Who Can Join the Study?

You must provide informed consent, which means you agree to participate in the study before any study procedures begin
You can be female or male
You must be 18 years of age or older
You must have tried at least one time in the past to lose weight through diet without success
Your body mass index must be 27.0 or higher. Body mass index is a number calculated from your weight and height that shows if you are overweight
You must have been diagnosed with type 2 diabetes at least 180 days before joining the study. Type 2 diabetes is a condition where your body does not use insulin properly, causing high blood sugar levels
You must be managing your diabetes through lifestyle changes alone, or taking 1 to 3 diabetes medications by mouth at the same dose for at least 90 days before joining the study. These medications may include metformin, alpha-glucosidase inhibitors, glinides, SGLT2 inhibitors, thiazolidinediones, DPP-4 inhibitors, or sulphonylureas
A small number of participants may also be taking GLP-1 medications at a stable dose for at least 1 year, or basal insulin at a minimum dose that has been stable for at least 90 days. Basal insulin is a long-acting insulin that helps control blood sugar throughout the day

Who Cannot Join the Study?

The study does not list specific exclusion criteria, which are conditions or situations that would prevent someone from joining the trial
However, based on the study design, you should not participate if you do not have overweight or obesity, meaning if your body weight is not above the healthy range for your height
You should not participate if you do not have type 2 diabetes, which is a condition where your body does not use insulin properly, causing high blood sugar levels
You cannot participate if you are outside the age range accepted for this study
You cannot participate if you are part of a vulnerable population that requires special protection in research studies

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu	Osijek	Croatia

Other Sites

Site Name	City	Country
University Hospital Bratislava	Bratislava	Slovakia
Clinica Korall S.R.L.	Satu Mare	Romania
Qualiclinic Kft.	Budapest	Hungary
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice	Krapinske Toplice	Croatia
EUC Klinika Praha a.s.	Prague	Czechia
DIAB s.r.o.	Roznava	Slovakia
Iridia s.r.o.	Turciansky Peter	Slovakia
Sc Cmi Dr. Pletea Noemi S.R.L.	Bacau	Romania
Milena Sante S.R.L.	Galati	Romania
Komaromi Selye Janos Korhaz	Komarom	Hungary
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
University Of Debrecen	Debrecen	Hungary
Opca Bolnica Karlovac	Karlovac	Croatia
Poliklinika Solmed d.o.o.	Zagreb	Croatia
MUDr. Alena Vachova	Ceske Budejovice	Czechia
Mrmmu Kezzoc seknlk	Prague	Czechia
Daroeb Map Sdrtaw	Bucharest	Romania
Duqumgn Djd Pstsojv Anqwvhujcqf Sgcaje	Ploiesti	Romania

Trial status

Country	Status	Recruitment Start
Croatia	Not recruiting	05.11.2025
Czechia	Not recruiting	05.11.2025
Hungary	Not recruiting	05.11.2025
Romania	Not recruiting	05.11.2025
Slovakia	Not recruiting	05.11.2025

Trial locations

Investigated drugs:

Cagrilintide

Cagrilintide is an investigational medication given as an injection under the skin once a week. In this trial, it is being tested to help people with overweight or obesity and type 2 diabetes lose weight. It is used together with lifestyle changes such as diet and exercise counseling.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in the trial to compare how well cagrilintide works for weight loss.

Investigated diseases:

Overweight – Overweight is a condition where a person has excess body weight compared to what is considered healthy for their height. This occurs when the amount of energy taken in through food and drinks exceeds the amount of energy used by the body over time. The extra energy is stored as fat tissue in various parts of the body. Overweight develops gradually as body weight increases above normal ranges. The condition can exist on its own or progress to obesity if weight gain continues. People with overweight may experience changes in their physical function and overall quality of life.

Obesity – Obesity is a condition characterized by excessive accumulation of body fat that affects health and bodily functions. It develops when energy intake consistently exceeds energy expenditure over an extended period. As obesity progresses, fat deposits increase throughout the body, leading to changes in body composition and waist circumference. The condition often occurs alongside other health changes, including alterations in blood pressure, blood sugar levels, and blood fat levels. Obesity can affect physical function, mobility, and daily activities. The condition may also impact mental well-being and quality of life.

Type 2 Diabetes – Type 2 diabetes is a condition where the body cannot properly use or produce enough insulin, leading to elevated blood sugar levels. The condition typically develops gradually over time as the body becomes less responsive to insulin. As the disease progresses, the pancreas may struggle to produce sufficient insulin to maintain normal blood glucose levels. This results in persistently high levels of sugar in the blood, which can be measured through fasting plasma glucose and glycated haemoglobin tests. People with type 2 diabetes may experience episodes of low blood sugar, especially when taking certain medications. The condition often occurs together with overweight or obesity and affects various aspects of metabolism.

Trial ID:

2024-519531-41-00

Protocol code:

NN9833-8243

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing cagrilintide for weight loss in people with overweight or obesity and type 2 diabetes

What is this study about?

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