A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
This study is testing a new medicine called NNC0487-0111 for people who have heart failure and are also overweight or obese. Heart failure means your heart struggles to pump blood effectively, and excess weight can make this harder. The purpose of this research is to find out if NNC0487-0111 is safe and if it helps people with specific types of heart failure (HFpEF or HFmrEF) and who are overweight. Participants will receive either the new medicine or a placebo (a treatment with no active drug) once a week by injection. Which treatment you get is decided by chance, like flipping a coin. This medicine isn't available from doctors yet, but it has been tested in people before to check its safety.
At a glance
What is this study about?
This research study is investigating a new medication, NNC0487-0111, for individuals living with certain types of heart failure (HFpEF or HFmrEF) who also carry excess body weight. Heart failure, in simple terms, means your heart isn't pumping blood as well as it should. There are different kinds, and this study focuses on two where the heart muscle is stiff or only mildly weakened. Having excess body weight can often make heart conditions more challenging to manage, so finding new ways to help these patients is very important.
The main goal of this study is to understand if NNC0487-0111 is both safe and effective. Researchers want to see if it can improve the health and well-being of people who have these specific heart conditions and are also overweight. Doctors are always looking for better treatments, and studies like this are how new medicines are thoroughly tested before they can become available to everyone.
Participants in the study will be given either the active new medicine, NNC0487-0111, or a placebo. A placebo looks just like the real medicine but contains no active ingredients. This comparison helps researchers determine if any improvements seen are truly due to the new medicine or if they might be due to other factors. Importantly, which treatment you receive is chosen randomly, so neither you nor your study doctor can decide. The medicine will be given as a weekly injection.
Key takeaways
- This study investigates a new medicine for heart failure and obesity.
- It compares the new medicine (NNC0487-0111) to a dummy treatment (placebo).
- Participants will receive weekly injections, randomly assigned.
- The study aims to check if the new medicine is safe and effective.
- Close medical monitoring will be provided throughout the study.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you would need to be 18 years or older and have been diagnosed with heart failure that is stable. You would also need to have a Body Mass Index (BMI) of 30 or higher, which means you are considered obese.
There are also some conditions that would mean you couldn't take part. For example, if you've recently had a heart attack, stroke, or severe worsening of your heart failure, or if your heart failure is caused by certain rare conditions. Also, if you have severe lung problems or specific types of diabetes complications affecting your eyes, you might not be able to join.
The study also can't include people whose heart failure symptoms are thought to be caused by other specific health issues, like severe anaemia or an underactive thyroid, or if you have Type 1 diabetes. The research team will carefully check all these details with you to see if the study is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of heart failure that is stable?
- Is your Body Mass Index (BMI) 30 or higher (meaning you are obese)?
- Have you *not* had a recent heart attack, stroke, or severe worsening of your heart failure?
- Do you *not* have certain severe lung diseases or specific rare heart conditions?
- Are you *not* a person with Type 1 diabetes, or have certain severe eye problems due to diabetes?
What does participation involve?
If you decide to take part in this study, you would receive either the study medicine (NNC0487-0111) or a placebo, given as an injection once a week. You wouldn't know which one you are getting, and neither would your study doctor. This is done to make sure the results are as fair as possible.
Throughout the study, you would have regular visits to the clinic. At these visits, the study team would monitor your health closely. This would involve various assessments, such as physical exams, blood tests, heart checks (like ECGs), and discussions about how you are feeling and any side effects you might be experiencing. These visits are important for ensuring your safety and for gathering information about how the treatment is working.
The total duration of your participation in the study, including all treatments and follow-up assessments, would be explained to you in detail by the study team. They will also tell you how often these visits would be and what each visit would involve.
Potential risks and benefits
Locations (825)
- Advanced Cardiovascular, LLCVerified postcodeAlexander City, United States
- Univ of Alabama BirminghamVerified postcodeBirmingham, United States
- Eastern Shore Rsrch Inst, LLCVerified postcodeFairhope, United States
- Mobile Heart USA Health Cardiology ClinicVerified postcodeMobile, United States
- Mercy Gilbert Medical CenterVerified postcodeGilbert, United States
- Sun City Clinical ResearchVerified postcodeGlendale, United States
- Honor HealthVerified postcodePhoenix, United States
- Arizona Research CenterVerified postcodePhoenix, United States
- Arkansas Health GroupVerified postcodeLittle Rock, United States
- InvivoCure -2Verified postcodeAlhambra, United States
- Cardio Research of S. CalVerified postcodeBeverly Hills, United States
- Westside Medical Associates Los AngelesVerified postcodeBeverly Hills, United States
Common questions
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the new medicine's effects accurately.
Why can't my doctor prescribe this medicine now?
NNC0487-0111 is a new medicine still being tested. It needs to go through rigorous studies like this one to prove it's safe and effective before it can be approved for general use.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know which treatment you are receiving. This is called 'blinding' and helps ensure the study results are fair and unbiased.
What is 'heart failure with preserved ejection fraction' (HFpEF) or 'mildly reduced ejection fraction' (HFmrEF)?
These are kinds of heart failure where your heart struggles to pump blood effectively, either because it's too stiff to fill with blood properly (preserved ejection fraction) or because it's only mildly weakened (mildly reduced ejection fraction).
What happens after the study ends?
When the study ends, the researchers will analyse all the information gathered. Your study doctor will discuss your options for ongoing care, which would typically involve returning to your usual treatments.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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