Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J2O-MC-EKBC: KRAKEN: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Once-Daily LY3473329 in Adults with Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

This research study, called KRAKEN, is investigating a new medicine called LY3473329. It's for adults who have high levels of a specific type of cholesterol called Lipoprotein(a), often shortened to Lp(a). High Lp(a) can increase the risk of heart and blood vessel problems, like heart attacks or strokes. The study aims to find out if taking this new medicine once a day can effectively lower Lp(a) levels and if it is safe for people to use. To do this, some participants will receive the new medicine, while others will receive a 'dummy pill' (placebo) that looks the same but contains no active drug. This helps researchers understand the true effects of the investigational medicine compared to not receiving the active substance, ensuring unbiased results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co., Eli Lilly & Co.

Enrolment target

100

Start

09 Feb 2023

Lipoprotein Disorder

What is this study about?

This research study, known as KRAKEN, is focused on a new medication called LY3473329. It's being developed for adults who have higher-than-average levels of something called Lipoprotein(a), or Lp(a) for short. Lp(a) is a type of 'bad' cholesterol that, when levels are high, can increase a person's risk of developing serious heart and blood vessel problems, such as a heart attack or stroke.

The main goal of this study is to see how well this new medicine works at lowering Lp(a) levels in the blood. Researchers also want to understand if the medication is safe to use and what side effects, if any, it might cause. By comparing the new medication to a 'dummy pill' (placebo), the study helps doctors and scientists clearly see the actual effects of the investigational drug.

This is a 'Phase 2' study, which means it's still in the earlier stages of testing new medicines. At this stage, the focus is on finding the right dose and gathering more information about the drug's effectiveness and safety in a larger group of people than in earlier studies. The information gathered will help decide if the medicine should go on to larger, later-stage studies.

Key takeaways

This study is testing a new medicine (LY3473329) to lower high Lp(a) cholesterol.
It's for adults at higher risk of heart problems due to high Lp(a).
Participants will receive either the new medicine or a dummy pill.
The study aims to see how well the medicine works and if it's safe.
It's a 'Phase 2' study, an early step in medicine development.

Who may be eligible?

The KRAKEN study is looking for adult volunteers aged 18 and older. Both men and women are welcome to take part.

To join, you would need to have higher levels of Lipoprotein(a) (Lp(a)) in your blood. This is usually checked with a blood test. You would also need to be considered at a higher risk of heart and blood vessel problems by the study doctors.

The research team will carry out several health checks and ask about your medical history to make sure the study is a safe and suitable option for you. Not everyone who is interested will be able to take part, as specific health requirements must be met to ensure the study is safe and that the results are clear.

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 told you have high Lipoprotein(a) (Lp(a)) levels?
Are you considered by your doctor to be at high risk for heart or blood vessel problems?
Are you able to visit a study clinic regularly for health checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the KRAKEN study, you'll be assigned either the new medication or a matching 'dummy pill' (placebo) by chance. Neither you nor your study doctor will know which you are receiving. Over a period of about 12 weeks, you will take one pill by mouth once every day.

Your participation will involve several visits to the study clinic. These visits will include health checks, blood tests to measure your Lp(a) levels and other health markers, and discussions about how you're feeling and any effects you might be experiencing. These visits are important for monitoring your health and the effects of the medication. The research team will explain the exact schedule of visits and what each visit will involve.

Potential risks and benefits

Taking part in a research study has potential benefits and risks. You might benefit if the new medication helps lower your Lp(a) levels, which could reduce your future risk of heart and blood vessel problems, though this is not guaranteed. You would also be contributing to medical science, which could help others in the future. However, there's always a risk of side effects from any new medicine, and the 'dummy pill' might not offer any health benefits. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Hungary
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Unverified
Netherlands
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Unverified
Germany

Common questions

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

Lp(a) is a type of cholesterol in your blood. High levels can increase your risk of heart disease, even if your other cholesterol levels are normal.

What is a 'dummy pill' (placebo)?

A dummy pill looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine has an effect.

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

No, neither you nor your study doctor will know. This is called 'double-blind' and helps make sure the study results are fair and accurate.

How long will the study medication be taken for?

You would take the study medication once a day for about 12 weeks.

What does 'Phase 2 study' mean?

Phase 2 means it's an earlier stage of testing a new medicine. Researchers are looking closely at how well it works, its best dose, and its safety in a group of people.