J3E-MC-EZDB: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction (HFpEF)
This study is for adults who have a specific type of heart failure called 'Heart Failure with Preserved Ejection Fraction' (HFpEF), where the heart muscle is stiff and doesn’t fill with blood as well as it should. Researchers are testing a new medicine, LY3540378, to see if it can help improve how the heart works and make people feel better. Participants will be randomly given either the new medicine or a dummy medicine (placebo) that looks exactly the same, but no one will know who is getting what until the study ends. This helps scientists fairly compare the effects of the new medicine. The study will also carefully check for any side effects to make sure the medicine is safe.
At a glance
What is this study about?
Imagine your heart as a pump that sends blood around your body. With a condition called 'Heart Failure with Preserved Ejection Fraction' (HFpEF), the heart muscle becomes stiff and struggles to relax properly between beats. This means it can't fill with enough blood, leading to symptoms like breathlessness and tiredness, even though the heart can still pump blood out with enough force.
This study, called J3E-MC-EZDB, is a Phase 2 trial looking into a potential new medicine, LY3540378. Phase 2 means it's an early-stage study, and the main goal is to find out if this medicine can help improve how the heart works in people with HFpEF and if it's safe. Researchers will be especially interested in a specific measurement of heart function called 'Left Atrial Reservoir Strain' (LARS), which tells them how well a part of your heart (the left atrium) is stretching and filling with blood.
By comparing the new medicine to a 'placebo' (a dummy treatment), the researchers hope to understand if LY3540378 is truly effective at helping the heart work better and easing symptoms for people with this condition. This research is important because new treatments are needed for HFpEF, as it can significantly affect people's quality of life.
Key takeaways
- This study is for adults with Heart Failure with Preserved Ejection Fraction (HFpEF).
- It's testing a new medicine (LY3540378) to see if it improves heart function.
- Participants will receive either the new medicine or a dummy pill (placebo).
- Regular clinic visits, tests, and heart scans will be part of the study.
- The main aim is to understand if the medicine is effective and safe.
Who may be eligible?
This study is open to adults aged 18 and older. Both men and women can take part. The most important requirement is that you have been diagnosed with a specific type of heart failure called 'Heart Failure with Preserved Ejection Fraction' (HFpEF) and your condition is currently getting worse.
There will be other, more detailed criteria that the doctors will need to check to make sure the study is a good fit for you and that it's safe for you to take part. This might include checking your overall health, other medical conditions you have, and any other medications you are taking.
It’s crucial to discuss all your health details with the study team to see if you meet all the necessary requirements. They will be able to tell you if this study is right for you.
- Are you 18 years old or older?
- Have you been diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF)?
- Is your HFpEF condition currently getting worse?
- Are you able to attend regular clinic appointments and follow study instructions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the new medicine (LY3540378) or a dummy medicine called a placebo. Neither you nor your study doctor will know which one you are receiving. You will take this medicine for a set period. Throughout the study, you will have regular visits to the clinic.
During these visits, the study team will carry out various assessments. These will likely include physical examinations, blood tests, and special heart scans to see how your heart is working and to monitor any changes. They will also ask you questions about how you are feeling and any symptoms you might have. After you finish taking the study medicine, there will be follow-up visits to continue monitoring your health. The total duration of your participation in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —Hungary
- —Poland
- —Spain
- —Czechia
Common questions
What is Heart Failure with Preserved Ejection Fraction (HFpEF)?
It's a type of heart failure where your heart muscle is stiff, making it hard for your heart to fill properly with blood, even though it can still pump blood out with enough force.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the actual medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects fairly.
Will I know if I'm getting the new medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know who is getting which until the study is over.
How long will I be in the study?
The exact duration of the study for each participant will be explained by the study team if you are eligible.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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