RecruitingPHASE1INTERVENTIONAL

A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure

This research study is looking into a new medicine, NNC0537-1482, for individuals living with heart failure. The main goal is to understand if this new medicine is safe to use and how it affects the body. Participants will be randomly given either the new medicine or a placebo, which is a 'dummy drug' containing no active ingredients. The study involves a screening period of up to 28 days, followed by the treatment phase which lasts up to 64 days. This type of early-stage research is crucial for developing potential new treatments that could one day help many people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novo Nordisk A/S

Enrolment target

Start

23 Oct 2025

Estimated completion

15 Jan 2027

Heart Failure

What is this study about?

This research study is exploring a new medicine called NNC0537-1482, which could potentially help people who have heart failure. Heart failure means your heart isn't pumping blood around your body as well as it should. This can make everyday activities like walking or climbing stairs difficult, and you might feel tired or breathless.

The main purpose of this study is to find out if NNC0537-1482 is safe for people to take and to learn more about how it works within the body. This is an early stage of research, which is a really important step in developing new treatments. Researchers need to make sure a new medicine is safe before they can study how well it works to treat a condition.

By taking part, you could be helping scientists learn more about heart failure and develop new ways to manage it, potentially benefiting many others in the future. You will be helping to advance medical knowledge, even if this particular medicine doesn't turn out to be the right one.

Key takeaways

This study is testing a new medicine (NNC0537-1482) for heart failure.
It's an early-stage study focusing on safety and how the medicine works.
You'll either get the new medicine or a dummy pill (placebo).
The study involves check-ups and lasts for up to 64 days, plus a screening period.
Your current heart failure medication routine needs to be stable to join.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a man or a woman who is not able to have children. You must be aged between 40 and 75 years old, and your Body Mass Index (BMI) should be between 18.5 and just under 40. You must have heart failure that causes symptoms, usually described as NYHA Class II or III, meaning you have some limitations in your daily activities due to your heart.

It's important that your current heart failure medicines have been stable for a certain amount of time before the study starts. This includes medicines like ACE inhibitors, beta-blockers, and diuretics. You shouldn't have been in hospital for heart failure between your first check-up and when you start the study. Your heart's pumping ability, measured by something called ejection fraction, needs to be over 40%.

Finally, a specific blood test called NT-proBNP needs to show certain levels, depending on whether you have a normal heart rhythm or a condition called atrial fibrillation. These are all important checks to make sure the study is suitable for you and to keep you safe.

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 between 40 and 75 years old?
Are you a man, or a woman who cannot have children?
Do you have heart failure symptoms that affect your daily life?
Has your heart failure medication been stable recently, with no big changes?
Have you not been in hospital for heart failure in the last few weeks?
Has your heart's pumping ability (ejection fraction) been measured above 40%?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening period that can last up to 28 days. During this time, doctors will do checks and tests to see if the study is right for you. If you qualify, you'll then be in the main part of the study for up to 64 days.

Throughout the study, you'll either receive the new medicine, NNC0537-1482, or a placebo (a 'dummy' pill that looks like the study medicine but has no active ingredients). Which one you get is decided completely by chance. You won't know which one you're taking, and neither will the study doctors or nurses, to make sure the results are fair.

Your participation will involve several visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and how you're responding to the treatment. The exact number of visits will be explained by the study team. You'll be given the study medicine to take at home, and the team will tell you exactly how and when to take it.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you would receive close medical monitoring and potentially gain access to a new medicine that isn't yet available. However, there's no guarantee the new medicine will help you, as it's still being tested. Regarding risks, side effects from the study medicine are possible, just like with any medicine. Some people might experience side effects even from the placebo. All potential risks will be fully explained by the study team before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Richmond Pharmacology
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as effectively as it should. It doesn't mean your heart has stopped working, but it can lead to symptoms like breathlessness and tiredness.

What is a placebo?

A placebo is often called a 'dummy drug'. It looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare against the real medicine to see if the new medicine is actually having an effect.

Why is this study being done?

This study is an early step to see if a new medicine, NNC0537-1482, is safe for people with heart failure and to understand how it works in the body. This information is vital for developing new treatments.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor the doctors will know which treatment you are receiving. This is called 'blinding' and helps ensure the study results are as accurate and unbiased as possible.

How long will I be in the study?

The study involves a screening period of up to 28 days to see if you can join, followed by the main treatment part which lasts up to 64 days. So, the maximum total time is about 3 months.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.