Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C3651011 - A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT PARTICIPANTS WITH HEART FAILURE

This research study is investigating a new medication called ponsegromab for adults suffering from heart failure. Heart failure can make everyday tasks difficult and reduce your overall quality of life. The study aims to find out if ponsegromab can improve symptoms such as breathlessness, fatigue, and how well people can carry out their daily activities. Participants will receive either ponsegromab or a placebo (a dummy medicine) by injection. We will compare these two groups to see if the new medicine makes a real difference to patients' well-being and measure any side effects, ensuring it is safe to use. This information will help us understand if ponsegromab could be a helpful future treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

155

Start

12 Apr 2024

Heart failure

What is this study about?

Heart failure is a condition where your heart can't pump enough blood around your body to meet its needs. This can lead to symptoms like feeling very tired, breathless, and finding it hard to do everyday things. Living with heart failure can affect your overall quality of life, making it difficult to enjoy activities you once did. This study is dedicated to finding better ways to help people manage these challenges.

We are testing a new medicine called ponsegromab. Right now, we don't know for sure if it will help people with heart failure, which is why we need to do this study. By comparing ponsegromab to a placebo (a substance that looks like the medicine but has no active ingredient, often called a dummy medicine), we can accurately see if any changes we observe are truly due to the new medication or just happen naturally over time.

The main goal of this study is to see if ponsegromab can improve participants' day-to-day symptoms, how well they can manage physical activities, and their overall quality of life after a period of treatment. We will also carefully monitor the medication's safety and check for any side effects. The results from this study will help us understand if ponsegromab has the potential to become a new and effective treatment option for heart failure patients in the future.

Key takeaways

Tests a new medicine, ponsegromab, for heart failure.
Compares ponsegromab to a placebo (dummy medicine).
Focuses on improving symptoms, physical ability, and quality of life.
Participation lasts about 5-6 months with regular clinic visits.
Safety and side effects will be carefully monitored.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. We welcome both men and women to participate.

Beyond these basic requirements, there will be specific health criteria that you'll need to meet. For example, the study team will need to confirm that your heart failure is of a certain type or severity. They will also review your medical history to make sure that taking part in the study would be safe for you and won't interfere with any other health conditions or medicines you're currently taking.

The study doctors and nurses will explain all these details clearly and check if you're a good fit for the study during an initial screening visit. They are there to answer any questions you might have about whether this study is right 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?
Have you been diagnosed with heart failure?
Are you able to attend regular clinic appointments for about 5-6 months?
Are you willing to consider receiving either the new medicine or a dummy medicine?
Are you currently living in the UK where the study is taking place?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be asked to attend several visits at the study clinic over a period of about 22 weeks, which is roughly 5-6 months. During these visits, nurses and doctors will perform various checks, such as measuring your heart function, asking about your symptoms and how you feel generally, and taking blood samples.

You would receive regular injections under your skin, which will either be the study medicine, ponsegromab, or the placebo. You won't know which one you are getting, and neither will the study team, to ensure the results are fair. You'll also likely be asked to complete questionnaires about your health and how you're feeling, including questions about your energy levels and how easily you can do physical tasks. The total duration of your active involvement in the study will be around 22 weeks, with follow-up appointments to monitor your health.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as contributing to scientific understanding that could lead to new treatments for heart failure. You would also receive regular medical attention and monitoring throughout the study. However, there's no guarantee that the study medicine will help you, and you might experience side effects from the medication. As with any injection, there's a small risk of discomfort or bruising at the injection site. All possible risks will be explained to you before you agree to take part. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Germany
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Unverified
Poland
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Unverified
Hungary
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Unverified
Czechia
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Unverified
Spain

Common questions

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare if a new medicine truly makes a difference.

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

No, neither you nor the study team will know whether you are receiving the real medicine (ponsegromab) or the placebo. This helps ensure the study results are fair and unbiased.

What does 'heart failure' mean in this study?

Heart failure means your heart isn't pumping blood as well as it should, leading to symptoms like tiredness and breathlessness. This study is for adults diagnosed with this condition.

How will the study measure if the treatment is working?

We'll use questionnaires about your symptoms and quality of life, physical activity tests (like walking tests), and monitor your general health to see if the medicine helps.

Where does this study take place?

The study will take place at specific clinics or hospitals. The study team will provide you with details about the location of the study site.