This study is funded and sponsored by Novo Nordisk.

Thank you for expressing an interest in the REDEFINE 3 study. If you are interested in taking part in this study, this website is for you. Here you will find details of the study, including the criteria used by the research team to see if this study is suitable for you. 

On this website you can: 

Learn more about the REDEFINE 3 study 

Find out if you meet some basic criteria to take part

Discover what is expected from people who agree to take part

Contact your local centre to find out more about the study

What is the REDEFINE 3 study?

REDEFINE 3 is looking at a study medicine to assess how effective it is for reducing cardiovascular events, such as heart attack and strokes, in people who are overweight or living with obesity.

Further information about the study and why it is important 

We are doing this study to see if the study medicine, being developed to treat overweight and obesity, is effective at reducing cardiovascular events in people who are overweight or living with obesity who also have cardiovascular disease. The study will also include some people with type 2 diabetes and/or chronic kidney disease. 

The term cardiovascular disease is used to describe a group of conditions that affect your heart and blood vessels. These conditions include myocardial infarction (also known as heart attack), stroke, and peripheral arterial disease (also known as poor circulation).  

Obesity is when your body stores too much fat. People living with obesity are more likely to have cardiovascular conditions and get other diseases such as type 2 diabetes.  

Taking part in this clinical study may improve future treatment options for people who are living with both obesity or overweight and cardiovascular disease.

Have you ever had a heart attack or stroke?​ Or do you have poor circulation? Are you overweight or living with obesity?

You may be able to take part if: 

  • You have had a stroke, a heart attack (myocardial infarction), or have poor circulation (peripheral arterial disease, or PAD) 

  • You are 55 years of age or older 

  • If you're overweight or living with obesity (BMI over 25)

  • You are able to attend regular clinic visits (ranging from every 4 – 12 weeks depending on the  stage of the study) and receive phone calls over a period of up to 4.5 years 

What to expect if you join the study: 

We are doing this study to look at the effects of the study medicine on cardiovascular events, such as heart attack and stroke, in people who are overweight or living with obesity and cardiovascular disease. An ‘event’ is a single occurrence of an illness. For example, if you had a heart attack last week, that would be known as a medical event.  

If you are eligible and join the study, you will either get the study medicine or a dummy medicine (known as a placebo) which has no effect on the body. Which treatment you get is decided by chance. Your chance of getting the study medicine or placebo is the same.  

Whether you have the placebo or the study medicine, you will have one injection every week and most of these you will give yourself at home. The injections use a thin needle, typically in the stomach, thighs or upper arms.

The study will last for up to 4.5 years and will require up to 27 clinic visits (ranging from 4 – 12 weeks apart depending on the stage of the study). The visits will be with the study doctor or study staff. You will have blood samples taken at most of the clinic visits. You will also have urine samples taken at some visits.  

FAQs

  • This study will mainly look at the effects of the study medicine on cardiovascular events (for example heart attack and stroke) in people who are overweight or living with obesity and cardiovascular disease.  

  • Approximately 7,000 men and women across the world will take part in this study. 

  • You cannot take part in this study if you are already taking part in another study testing a medicine or treatment. You must not join other studies that are testing a medicine or treatment if you decide to take part in this study. This is for your safety and to make sure the outcomes of the study are accurate. 

  • You can decide if you no longer wish to take part in the study at any time − you do not have to give a reason. If you decide to stop taking part in the study:

    • Your future medical care will not be affected

    • You will continue to be treated as you were before you started this study. 

    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. 

  • You will take the study medicine with a pen injector. A pen injector is a tool with a needle used for injections under the skin. The study doctor or site staff will show you how to use the pen and inject the study medicine. 

    • You need to inject the study medicine, typically in the stomach, thighs or upper arms 

    • The injections should be taken once a week 

    • The injections should be taken on the same day of the week 

    • You will take the study medicine at home  

    During the study, you need to store and take the study medicines as directed by your study doctor. 

  • The total time you will be in this study is up to 4.5 years. This includes:

    • Up to 3 weeks at the start to check if you can take part in the study. This is called the screening process.

    • 16 weeks where you will slowly increase the dose of the study medicine.

    • 235 weeks where you will take the same dose of either the study medicine or the “dummy” medicine each week

    • 7 weeks after your last dose of study medicine you will have a final study visit where there will be a check on your general health

  • You might be asked to take a COVID-19 test if your doctor thinks you could have COVID-19. 

    If you get COVID-19 before you receive the study medicine for the first time, you should not come to the clinic until the study team confirm you can. 

    If you get COVID-19 or symptoms of COVID-19 during the study, you should inform your study doctor straight away. The study doctor may pause your study medicine for a while. If your study doctor pauses your study medicine, they will also tell you when you can start taking the study medicine again. 

    Other tests related to COVID-19 may be made. Your study doctor will give you more information about this. 

  • The study medicine you get is decided by chance − like flipping a coin. This is called randomisation. 

    • A computer programme decides which study medicine each person gets. 

    • Half of the participants will get the 'study medicine; the other half will get the “dummy” medicine.  

    You or your study doctor will not know which of the study medicines you will get. However, if your safety is at risk, your study doctor will be told in order to help make decisions about your medical care. 

  • All participants will be reimbursed for travel expenses for clinic visits.

  • The study is funded by Novo Nordisk, a leading global healthcare company, founded in 1923 and headquartered in Denmark.