Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2, randomised, double-blind, placebo-controlled trial to evaluate safety and local tolerability of four weekly administrations of A24110He in subjects with elevated triglyceride plasma concentrations

This research study is looking at a new investigational medicine, A24110He, for adults who have particularly high levels of triglycerides, a type of fat in the blood. High triglycerides can be a concern for your heart health. The main goal of this study is to check how safe the new medicine is and how well the body tolerates it, especially around the injection site. Participants will be randomly assigned to receive either A24110He or a placebo (a dummy treatment without the active medicine) over four weeks. We'll be carefully monitoring various health markers and any side effects during this time to understand the medicine's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Lipigon Pharmaceuticals AB

Enrolment target

Start

06 Feb 2024

Moderate to severe hypertriglyceridemia

What is this study about?

This study is a medical research trial looking into a new treatment called A24110He. It's designed for people who have moderate to severe hypertriglyceridemia, which simply means they have very high levels of a type of fat called triglycerides in their blood. While triglycerides are important for energy, having too much can be harmful to your health.

In this 'Phase 2' study, we're particularly interested in understanding if A24110He is safe for people to use and how well their body handles it, especially where the injection is given. We'll be comparing the new medicine to a 'placebo' – a dummy treatment that looks just like the real medicine but contains no active ingredients. This helps scientists to truly see the effects of the new medicine. Participants will receive the treatment for four weeks.

The information gathered from this study will help us learn more about A24110He. It will tell us how the medicine behaves in the body and if it has any noticeable effects on triglyceride levels. This type of research is a crucial step in developing new treatments and understanding their potential benefits and risks for patients.

Key takeaways

This study is for adults with high blood triglyceride levels.
It tests a new medicine (A24110He) for safety and how the body handles it.
Participants will receive either the new medicine or a dummy treatment (placebo).
Treatment is given weekly for four weeks.
Your health will be closely monitored with tests and check-ups.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old.

The most important health condition for this study is having moderate to severe hypertriglyceridemia. This means your doctor has told you that you have particularly high levels of a certain type of fat, called triglycerides, in your blood.

There may be other specific health requirements or conditions that would prevent you from taking part, but these will be discussed in detail by the study team if you express interest.

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 moderate to severe hypertriglyceridemia (very high blood fats)?
Are you able to attend regular clinic visits for blood tests and check-ups?
Are you able to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you might receive the new medicine A24110He or a placebo (a dummy treatment). The treatment will be given weekly for four weeks. Throughout the study, the research team will keep a close eye on your health.

This will involve several visits to the clinic where you'll have various check-ups. These include general physical exams, measurements like your blood pressure, heart rate, and temperature, and regular blood and urine tests. These tests are important to check your overall health and how your body is reacting to the treatment.

You'll also have a special heart test called an ECG. The study team will ask you about any side effects you might experience. The total duration of active treatment is four weeks, but there will be follow-up appointments to ensure your continued well-being.

Potential risks and benefits

It's important to understand that in any clinical study, there are potential benefits and risks. You might not directly benefit from taking part, but your involvement could help us learn more about this condition and potentially help others in the future. We'll be carefully monitoring your health throughout the study, looking for any unexpected effects. There's a chance you might experience side effects from the study medicine or discomfort from the procedures like blood tests. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Sweden

Common questions

What are triglycerides?

Triglycerides are a type of fat found in your blood. Your body uses them for energy. If you have too many, it can be a concern for your health.

What does 'randomised' mean?

It means you'll be assigned by chance, like flipping a coin, to either receive the new medicine or a dummy treatment (placebo). Neither you nor the study team will know which you're getting.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. This helps us see if the new medicine is truly effective.

What does a 'Phase 2' study mean?

Phase 2 studies are early-stage research. They focus on finding out if a new medicine is safe, if it has any effect, and what dose might be best.

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 whether you're receiving the active medicine or the placebo. This helps prevent any bias in the results.