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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J3L-MC-EZEB: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3819469 in Adults with Elevated Lipoprotein(a)

This study, called J3L-MC-EZEB, is investigating a new medicine, LY3819469, in adults who have high levels of a type of cholesterol called Lipoprotein(a), or Lp(a). High Lp(a) can increase the risk of heart problems. The researchers want to find out if LY3819469 can effectively lower Lp(a) levels and if it is safe for people to take. Participants will be randomly assigned to receive either the new medicine or a placebo (a dummy pill that looks just like the medicine but contains no active ingredient). This is a 'double-blind' study, meaning neither the participants nor the doctors will know who is getting the real medicine, which helps ensure fair results. The study will look at how much Lp(a) levels change over several months.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Eli Lilly & Co.
Enrolment target
125
Start
24 Jan 2023

What is this study about?

You might have heard of 'good' and 'bad' cholesterol. Lipoprotein(a), often shortened to Lp(a), is another type of fat-like substance in your blood, similar to cholesterol. For some people, having high levels of Lp(a) can be a problem because it's thought to make blood vessels ‘stickier’, potentially increasing the risk of heart and blood vessel disease. Currently, there aren't many specific treatments for high Lp(a), so finding new and effective ways to manage it is important.

This study, called J3L-MC-EZEB, is a Phase 2 trial. This means it's an important step in testing a new medicine that has already shown some promise in earlier, smaller studies. The main goal is to understand if a new medicine called LY3819469 can effectively lower Lp(a) levels in adults who have higher-than-normal amounts. It will also carefully check for any side effects to make sure the medicine is safe. By learning more about LY3819469, researchers hope to find a new way to help people manage their Lp(a) levels and potentially reduce their risk of serious health problems.

To make sure the study results are as reliable as possible, it's designed as a 'randomized, double-blind, placebo-controlled' study. 'Randomized' means participants are put into groups by chance, like flipping a coin. 'Double-blind' means neither you nor your study doctor will know if you're receiving the actual medicine or a 'placebo' (a dummy pill). The 'placebo' looks exactly like the real medicine but contains no active ingredients. Comparing the new medicine to a placebo helps researchers see if any changes are truly due to the medicine and not just other factors or simply believing you're getting treatment. This approach helps get a clearer picture of the medicine's real effects.

Key takeaways

  • This study is testing a new medicine (LY3819469) for high Lipoprotein(a).
  • It's open to adults aged 18 and over with elevated Lp(a) levels.
  • Participants will receive either the medicine or a dummy pill (placebo).
  • The study aims to see if the medicine is safe and effective in lowering Lp(a).
  • Regular clinic visits and blood tests will be part of taking part.
  • You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

This study is open to adults aged 18 and over. It's designed for people who have been found to have higher-than-normal levels of Lipoprotein(a) (Lp(a)).

To join, there will be specific health checks to make sure the study medicine is right and safe for you. These checks are important to protect your health and to ensure the study results are accurate. For example, your current health, other medicines you might be taking, and past medical conditions will all be considered.

If you're interested, the study team will go through all the entry requirements with you in detail. They will explain why certain things might make you eligible or ineligible. This ensures that the study is suitable for you personally.

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.

  1. Are you 18 years old or older?
  2. Have you been told you have high Lipoprotein(a) (Lp(a))?
  3. Are you willing to attend regular clinic visits and have blood tests?
  4. Are you prepared to take a study medicine (or a dummy pill) regularly?
  5. Are you able to understand and agree to the study requirements?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in it for a number of months. You'll visit the clinic regularly for check-ups. At these visits, the study team will take blood samples to check your Lp(a) levels and other health markers, and they'll ask you about how you're feeling and any side effects you might be experiencing. You will be given either the study medicine (LY3819469) or a placebo (a dummy pill) to take regularly, as instructed by the study team. Both you and your doctor will not know which one you are taking. There will be follow-up appointments after you finish taking the medicine to make sure you are well and to collect final information. The exact number of visits and the full length of the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might benefit from closer medical attention and potentially receive a new medicine that could lower your Lp(a) levels if it proves effective and you receive the active drug. However, there's no guarantee that the study medicine will help you, and you might receive the placebo. There's also a possibility of experiencing side effects from the study medicine, some of which may be unknown. All known risks will be fully explained to you. Remember, you can choose to leave 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.
  • Unverified
    Denmark
  • Unverified
    Spain
  • Unverified
    Netherlands
  • Unverified
    Romania
  • Unverified
    Germany

Common questions

What is Lipoprotein(a) or Lp(a)?

Lp(a) is a type of fat-like substance in your blood, similar to cholesterol. High levels are linked to an increased risk of heart disease.

Why is this study 'double-blind'?

Being 'double-blind' means neither you nor your doctor knows if you're getting the active medicine or a dummy pill (placebo). This helps make sure the study results are fair and accurate.

What is a Phase 2 study?

A Phase 2 study is a stage where a new medicine is tested in a larger group of people to see if it works and what its side effects might be, after initial safety checks.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related care and medication will be provided free of charge.

What if I experience side effects?

You should report any changes in how you feel or any new symptoms to the study team immediately. They will monitor you closely and provide care as needed.

How to find out more

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

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