RecruitingPHASE3INTERVENTIONAL

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

This research study is investigating a new medicine called ziltivekimab for individuals diagnosed with both heart failure and inflammation. The main goal is to determine if ziltivekimab is effective compared to a placebo, which is an inactive substance that looks just like the study medicine. Participants will be randomly assigned to receive either ziltivekimab or the placebo, meaning there's an equal chance of getting either. It's important to know that ziltivekimab is a new medicine and is not currently available from doctors. The study is planned to last for approximately 1 year and 4 months in total. This type of study, called a Phase 3 trial, is a crucial step in evaluating new treatments before they can be considered for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

680

Start

01 Apr 2024

Estimated completion

08 Jan 2027

Heart Failure Systemic Inflammation

What is this study about?

This research study is looking for new ways to help people who have both heart failure and ongoing inflammation in their body. Heart failure means your heart isn't pumping blood as well as it should, which can make you feel tired or short of breath. Inflammation is a natural response of your body, but long-term inflammation can sometimes make heart conditions worse. Doctors are interested in whether a new medicine called ziltivekimab could help manage this combination of conditions.

The study will compare ziltivekimab with a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active ingredients. This is a common and important way to test new medicines, as it helps researchers see if any improvements are truly due to the new medicine or just to other factors. Participants will be randomly assigned to receive either ziltivekimab or the placebo, ensuring a fair comparison.

Ziltivekimab is still in the testing phase, meaning it hasn't been approved for use by doctors yet. This study is a crucial step to understand its effects, potential benefits, and any side effects. By taking part, you could be helping to find new treatments that could improve the lives of many people with heart failure and inflammation in the future.

Key takeaways

Tests a new medicine (ziltivekimab) for heart failure and inflammation.
Compares ziltivekimab to an inactive dummy medicine (placebo).
Treatment chosen randomly (like flipping a coin).
Study lasts up to 1 year and 4 months.
Ziltivekimab is not yet available to the public.
Close medical monitoring during the study.

Who may be eligible?

To be able to take part in this study, you would generally need to be an adult, aged 18 or older. Doctors will check your medical records and perform some tests to see if you meet specific health requirements. These typically include having a certain level of inflammation in your blood and specific measures related to your heart failure, such as how well your heart pumps blood and the size or thickness of certain parts of your heart.

You also need to have been diagnosed with heart failure that falls into certain categories (specifically NYHA Class II or III, which describes how much your symptoms limit your daily activities). Importantly, you shouldn't have had any recent hospital stays or urgent doctor visits for your heart failure. There will also be a short walking test to check your general fitness and ability to take part.

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?
Have you been diagnosed with heart failure?
Do you have a certain level of inflammation in your blood?
Have you avoided any recent hospital stays or urgent doctor visits for heart failure?
Can you walk at least 100 metres in 6 minutes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance to receive either the new medicine, ziltivekimab, or a placebo (a dummy medicine). You wouldn't know which one you are receiving. The study involves regular visits to the clinic where you would have various health checks, such as blood tests, heart scans, and physical examinations. You would receive your assigned treatment during these visits.

Throughout the study, the research team will closely monitor your health and any changes you experience. Your safety is their top priority. The total time you would be involved in the study is expected to be up to 1 year and 4 months, including regular follow-up appointments to track your progress and well-being after you stop taking the study medicine.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new medicine that could help your condition. However, ziltivekimab is a new medicine, so not all its effects are known, and there's a chance it might not help or could cause side effects. Like any medication, there could be risks associated with taking it, or the placebo. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (240)

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

Advanced Cardiovascular, LLC
Verified postcode
Alexander City, United States· Completed
Eastern Shore Rsrch Inst, LLC
Verified postcode
Fairhope, United States· Active not recruiting
Cardiology & Medicine Clinic
Verified postcode
Little Rock, United States· Completed
Valley Clinical Trials, Inc.
Verified postcode
Northridge, United States· Active not recruiting
Valley Clinical Trials, Inc.
Verified postcode
Northridge, United States· Recruiting
UCI Health
Verified postcode
Orange, United States· Completed
South California Heart Spc
Verified postcode
Pasadena, United States· Active not recruiting
Clearwater Cardiovascular Consultants
Verified postcode
Largo, United States· Completed
Clearwater Cardiovascular Consultants
Verified postcode
Largo, United States· Recruiting
Ocala Cardiovascular Research
Verified postcode
Ocala, United States· Active not recruiting
Ormond Beach Clinical Research
Verified postcode
Ormond Beach, United States· Active not recruiting
St Johns Ctr Clin Rsch-St. Aug
Verified postcode
Saint Augustine, United States· Active not recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as efficiently as it should. This can lead to symptoms like breathlessness, tiredness, and swelling.

What does 'inflammation' mean in this study?

Here, inflammation refers to a natural process where your body reacts to injury or illness. In this study, doctors are looking at ongoing inflammation that might affect your heart health.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study medicine but contains no active ingredients. It's used to compare against the real medicine to see if the new treatment truly works.

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

No, you won't know. This is called a 'blinded' study, which helps ensure the results are fair and accurate without anyone's expectations influencing them.

Is ziltivekimab available from my doctor now?

No, ziltivekimab is still an experimental medicine. It's not yet approved by health authorities, so doctors cannot prescribe it outside of research studies.

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.