A Study of Cagrilintide and Semaglutide for Weight Loss in People with Type 2 Diabetes and Overweight or Obesity

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What is this study about?

This study involves people who have type 2 diabetes and are living with excess body weight or obesity. The treatment being tested is a combination of two medications called cagrilintide and semaglutide, which together are referred to as CagriSema. This combination is given as an injection under the skin once a week. Some people in the study will receive placebo instead of the active medications. All participants will also be asked to follow a reduced-calorie diet and increase their physical activity during the study.

The purpose of this study is to find out how well CagriSema works in helping people lose weight compared to placebo, when used together with diet and exercise changes. The study will also look at whether people can achieve certain weight loss goals, such as losing at least five percent or twenty percent of their body weight. Additionally, the study will examine how the treatment affects waist size, blood sugar control measured by a test called HbA1c, blood pressure, and quality of life related to physical function. The safety of the treatment will be carefully monitored by tracking any unwanted effects that occur during the study, including episodes of low blood sugar.

During the study, participants will receive their assigned treatment for up to one year. Throughout this time, they will have regular visits where doctors will check their weight, blood sugar levels, blood pressure, and overall health. The study will collect information about how the treatment affects the body and whether it causes any side effects. This research aims to provide information about whether this combination treatment could be a helpful option for people with type 2 diabetes who are also struggling with excess weight.

1 Initial treatment period begins

Your participation in the study will start after you have completed all screening procedures and have been accepted into the trial.

You will be assigned to receive either CagriSema (a combination of cagrilintide and semaglutide) or placebo (an inactive substance that looks like the study medication but contains no active ingredients).

The assignment will be done randomly, which means it will be determined by chance, similar to flipping a coin.

2 Medication administration

You will receive injections under the skin (subcutaneous injections). This means the medication will be injected into the fatty tissue just beneath your skin.

The medication is provided as a solution for injection.

You will need to administer the injections once weekly, meaning one injection per week.

The exact dosage will be determined by the study protocol and may be adjusted during the course of the trial.

3 Lifestyle modifications

Throughout the study, you will be expected to follow a reduced-calorie diet. This means eating fewer calories than you normally would.

You will also be expected to increase your physical activity levels as part of the treatment plan.

These lifestyle changes are an important part of the study and should be maintained throughout your participation.

4 Continuation of diabetes medications

If you are currently taking oral antidiabetic drugs (medications taken by mouth to manage diabetes), you will continue taking them during the study.

These medications may include metformin, medications that slow down sugar absorption in the intestines, medications that help your pancreas release insulin, medications that help your kidneys remove sugar through urine, or other diabetes medications.

Your diabetes medication regimen should remain stable throughout the study, meaning the same medications at the same doses.

5 Regular monitoring visits

You will attend regular study visits where various measurements and assessments will be performed.

Your body weight will be measured regularly to track changes throughout the study.

Your waist circumference will be measured to assess changes in body composition.

Blood samples will be taken to measure your HbA1c (a measure of your average blood sugar levels over the past 2-3 months).

Your blood pressure will be checked, with particular attention to the upper number (systolic blood pressure).

You will be monitored for any side effects or health changes that may occur during the study.

6 Quality of life assessments

You will be asked to complete questionnaires about how your weight affects your daily life and physical functioning.

These questionnaires will help assess whether the treatment improves your quality of life and ability to perform physical activities.

The assessments will be repeated at various time points during the study.

7 Safety monitoring

Throughout the study, any adverse events (unwanted or unexpected medical occurrences) will be recorded and monitored.

Special attention will be paid to episodes of hypoglycaemia (low blood sugar), which can occur when blood sugar drops below normal levels.

You should report any symptoms such as shakiness, sweating, confusion, or dizziness, as these may indicate low blood sugar.

Severe episodes requiring assistance from another person will be carefully documented.

Any serious health problems that occur during the study will be closely monitored and reported.

8 Study completion

The study treatment period will continue for the duration specified in the study protocol.

Final assessments will be performed to evaluate the overall effects of the treatment on your weight, blood sugar control, and general health.

After completing the study, your doctor will discuss the next steps for managing your diabetes and weight.

Who Can Join the Study?

You can be male or female
You must be 18 years old or older when you sign the consent form to join the study
Your BMI (body mass index, a measure of body fat based on height and weight) must be 27.0 or higher
You must have been diagnosed with type 2 diabetes (a condition where your body does not use insulin properly, leading to high blood sugar levels) at least 180 days (about 6 months) before the screening visit
You must be managing your diabetes with either lifestyle changes alone (such as diet and exercise), or with 1 to 3 oral medications (pills taken by mouth) for diabetes. These medications can include metformin, alpha-glucosidase inhibitors, glinides, SGLT2 inhibitors, thiazolidinediones, or sulphonylureas, taken alone or in combination
If you are taking diabetes pills, you must have been on the same medication, dose, and schedule for at least 90 days (about 3 months) before the screening visit
Your HbA1c (a blood test that shows your average blood sugar level over the past 2 to 3 months) must be between 7% and 10% as measured at the screening visit

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent someone from joining this study
Typical exclusion criteria in clinical trials may include certain medical conditions, medications, or other factors, but these have not been specified in the available information

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Medical Concierge Centrum Medyczne	Warsaw	Poland

Verified Sites

Site Name	City	Country
Klinika Bellamed	Elblag	Poland
Imed19-Privat	Vienna	Austria
MVZ DiaMedicum Bad Mergentheim GmbH	Bad Mergentheim	Germany
MZM Praxis Drs. Erlinger	Stuttgart	Germany
Medical University Of Vienna	Vienna	Austria
Zentrum für klinische Studien Alexander Segner	St. Ingbert	Germany
Centrum Zdrowia Metabolicznego Paweł Bogdański	Poznan	Poland

Other Sites

Site Name	City	Country
Klinik Landstrasse	Vienna	Austria
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Ambenet GmbH Das Ambulante Behandlungsnetz	Leipzig	Germany
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.	Legnica	Poland
Instytut Diabetologii Sp. z o.o.	Warsaw	Poland
Terpa Sp. z o.o. sp.k.	Lublin	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP	Warsaw	Poland
Komaromi Selye Janos Korhaz	Komarom	Hungary
InnoDiab Forschung GmbH	Essen	Germany
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Private Practice – Dr. Evelyn Fließer-Görzer	St. Stefan ob Stainz	Austria
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
University Hospital Galway	Galway	Ireland
Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda	Germany
Salvia Lekston I Madej Sp. J.	Katowice	Poland
University Of Szeged	Szeged	Hungary
Zentrum für Klinische Forschung Allgäu Oberschwaben	Wangen im Allgäu	Germany
Institut fuer Diabetesforschung Muenster GmbH	Munster	Germany
Connolly Hospital	Dublin	Ireland
Cbweuxm Kllntpeemeseywklnd Gptvtaguspz Mdwqsx Gchhudh	Bydgoszcz	Poland
Twvfnxsp Svk z ogfp	Piotrkow Trybunalski	Poland
Sxszj Dyzlj Ewynygjgnylk Sjgigsofxdy Kguk	Budapest	Hungary
Gthakdj Lveraxyk Oidyhsnp i Cvqrcf Dagxbjoojuvhfd	Bialystok	Poland
Mwaolze Uxthzdhfjs Od Gcor	Graz	Austria
Uhbnugmbncjzyr Cdabbte Kkkkqyklf	Gdansk	Poland
Sg Vflrlkifnoxibqe Uzlmwxrfho Hixtykvm	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.02.2023
Germany	Not recruiting	01.02.2023
Hungary	Not recruiting	01.02.2023
Ireland	Not recruiting	01.02.2023
Poland	Not recruiting	01.02.2023

Trial locations

Investigated drugs:

Cagrilintide is a medication being tested to help people lose weight. It is given as an injection under the skin and works together with another medication to help reduce body weight in people who are overweight or have obesity and also have type 2 diabetes.

Semaglutide is a medication that helps with weight loss and blood sugar control. It is given as an injection under the skin and is being used in combination with cagrilintide in this trial to help participants lose weight while following a reduced-calorie diet and increasing physical activity.

CagriSema is a combination treatment that includes both cagrilintide and semaglutide together in one injection given under the skin once a week. This combination is being studied to see if it is more effective at helping people with overweight or obesity and type 2 diabetes lose weight compared to a placebo, when used along with eating fewer calories and being more physically active.

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 calories consumed exceeds the amount of energy the body uses over time. The extra energy is stored in the body as fat tissue. Overweight can develop gradually over months or years due to eating habits and reduced physical activity. The condition affects various body systems and can progress to more severe weight-related health problems. People with overweight may experience reduced mobility and changes in their physical functioning.

Obesity – Obesity is a condition characterized by excessive accumulation of body fat that affects health and bodily functions. It develops when energy intake from food consistently exceeds energy expenditure over an extended period. The excess fat is stored throughout the body and can affect multiple organ systems. Obesity typically progresses gradually and can worsen over time without lifestyle changes. The condition may lead to increased waist circumference and reduced physical capacity. People with obesity often experience impacts on their quality of life and daily physical activities.

Type 2 Diabetes Mellitus – Type 2 diabetes mellitus is a condition where the body cannot properly use or produce enough insulin, resulting in elevated blood sugar levels. The disease develops when cells become resistant to insulin or when the pancreas fails to produce sufficient amounts of this hormone. Blood sugar levels rise gradually and remain higher than normal throughout the day. The condition typically progresses slowly over time and may worsen without proper management. People with type 2 diabetes often experience changes in their glycated hemoglobin levels, which reflect long-term blood sugar control. The disease can affect blood vessels and various organs throughout the body as it advances.

Trial ID:

2023-506931-13-00

Protocol code:

NN9838-4609

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study of Cagrilintide and Semaglutide for Weight Loss in People with Type 2 Diabetes and Overweight or Obesity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?