Welcome to the Novo Nordisk
REIMAGINE 2 Clinical Study Webpage!
Here you will find information about our clinical research study and how you might be able to contribute, if you are eligible.
About the conditions
Type 2 diabetes is a condition affecting the body’s ability to control blood sugar levels.
After a meal, blood sugar levels are maintained by a process controlled by insulin, which enables the sugar from the meal to enter the cells in the body. In type 2 diabetes, the body does not produce or use insulin well and cannot keep blood sugar at normal levels. Over time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease. There is not a cure yet for diabetes, but keeping a healthy weight, eating healthy food and being active and taking medications that lower blood sugar can help.1
One group of people who have a high risk of developing type 2 diabetes are people living with overweight or obesity. Overweight and obesity is when your body stores too much fat. Treatment of overweight and obesity often includes lifestyle changes such as a healthy diet and more physical activity, as well as taking medications.2
Why we are doing this study
We are doing this study to look at how well our new investigational combination study medicine is at controlling blood sugar and help lose weight in people with type 2 diabetes and overweight or obesity. The researchers will compare the effect of the combination study medicine to a “dummy medicine” without any active ingredient.
Learn about our new investigational combination study medicine
CagriSema, the new investigational medicine being tested in this study, is a combination of two individual components: semaglutide and cagrilintide
Semaglutide: the approved individual component
The approved individual component is already approved for type 2 diabetes and weight management by the US Food and Drug Administration. It is similar to a hormone made in your body after eating a meal, called glucagon-like peptide-1 (GLP-1). It affects both your appetite and your body’s ability to regulate its blood sugar levels.
Like all medicines, the investigational study medicines may have side effects. If you want to see if you can take part in this study, please find more information and fill in the questionnaire at the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a clinical research site / hospital, where you will also get information about possible side effects of the investigational study medication.
You can read more about other general questions related to participation in a clinical study on our FAQ page.
Cagrilintide: the individual investigational component under development
The individual component under development is similar to a hormone made in the pancreas together with insulin, called amylin. Amylin is a hormone that is produced when you eat. It reduces the feeling of hunger before a meal and improves both the blood sugar levels and the feeling of fullness after a meal.
Like all medicines, the investigational study medicines may have side effects. If you want to see if you can take part in this study, please find more information, and fill in the questionnaire in the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a research site / hospital, where you will also get information about possible side effects of the investigational study medication.
You can read more about other general questions related to participation in a clinical study on our FAQ page.
What is a placebo?
A placebo is a “dummy” medicine that looks like the study medicine but has no active ingredient. The “dummy” medicine is in the study to see if the new investigational study medicine works as expected.
Like all medicines, the study medicines may have side effects. If you want to see if you can take part in this study, please find more information, and fill in the questionnaire in the bottom of the page. Depending on your answers you will be contacted within 48 hours for some additional information. If you fulfil the study criteria, you will be invited to an information meeting at a research site / hospital, where you will also get information about possible side effects of the study medication.
You can read more about other general questions related to participation in a clinical study on our FAQ page.
Study Details
In this clinical research study, the study participants will either get combination the new investigational study medicine in one of two doses (1.0 mg/1.0 mg or 2.4 mg/2.4 mg), its approved individual component (1.0 mg or 2.4 mg), its individual component under development (2.4 mg) or placebo (“dummy” medicine). Which treatment the study participants get is decided by chance. The treatment is given as an injection once a week throughout the treatment period. The study medicine is injected under the skin with a thin needle, in the thigh, stomach, or upper arm. The injection comes in the form of a pre-filled pen device.
Deciding if you want
to take part in the study
Time Commitment
The participation in the REIMAGINE 2 clinical research study will take about a year and a half at a clinical research clinic / hospital.
Responsibilities
If you take part in this study, you will be asked to attend a series of office or clinic visits and phone calls during the study. Study staff at a clinical research clinic / hospital will guide you through the necessary study assessments and explain the procedures.
If you want to see if you can take part in this study, please fill in the questionnaire at the bottom of this page, and depending on your answers you will be contacted within 48 hours for some additional information.
Please note: completing the questionnaire does not guarantee participation in the study.
You are welcome to stop your participation at any time
You can decide no longer to take part in the study at any time – you do not have to give a reason
- Your future medical care will not be affected if you stop taking part.
- Your existing relationships with
the hospital/clinic staff will not be impacted and you will continue
being personally treated in the same way.
- If you decide to no longer participate in the study, treatment with the investigational study medicine will be stopped immediately.
- If you decide to stop taking part during the study, information about you that has already been collected can still be used for research. This is required by the health authorities to make sure that the results for the entire study can still be used.
PLEASE NOTE: You cannot take part in this clinical research study if you are already taking part in another study that is testing a medicine or treatment. You must also not join other studies that are testing a medicine or treatment if you decide to take part in this study. This is to protect your safety and the outcome of this study.
How will you make a difference
Our new investigational combination study medicine may help people living with type 2 diabetes and overweight to gain a better control and lower their blood sugar levels and body weight.
By participating in this clinical research study, you can help researchers evaluate the above.
Also, the information we collect from you can help us better understand:
- Type 2 diabetes and overweight or related medical conditions
- How the study medicine works in the body
- How to improve the treatment of people with type 2 diabetes and overweight or related medical conditions
Join this study
If you are interested in the REIMAGINE 2 clinical research study or potentially would like to participate, please answer a couple of questions below and you will be contacted within 48 hours.
Thank you for taking the time to answer this short questionnaire.
At this point, the answers we have received do not match the inclusion criteria of this study. None of your data has been passed through to us at this point. If you are interested, please navigate to the Programme page of the REIMAGINE studies to see, if there are other studies that run in your country.
Thank you for taking the time to complete this questionnaire.
We have received your details, and our team will review your responses. We appreciate your interest in our research and will be in touch with you soon to discuss your eligibility and provide further information about the study.
Oops! Something went wrong
Apologies for the error encountered when submitting your data. No information has been passed on to us at this point and we will not be able to contact you. Please try again in a few hours. Thank you for your patience.
Please note:
- Completing the questionnaire does not guarantee participation in the study.
- Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who can become pregnant must use highly effective contraception and will need to take pregnancy tests throughout the study.
References
- World Health Organization. Diabetes. Fact sheet [Internet]. World Health Organization; 2021 Nov [cited 2023 Apr 4]. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes
- World Health Organization. Obesity and overweight. Fact sheet [Internet]. World Health Organization; 2021 Aug [cited 2023 Apr 4]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have questions regarding any information contained on this site you should consult a physician.
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