AuthorisedTherapeutic confirmatory (Phase III)Interventional

Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, with Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids)

The LIBerate-Kids study is testing a new medicine called lerodalcibep for children and teenagers between 6 and 17 years old who have Heterozygous Familial Hypercholesterolemia (HeFH). HeFH is a genetic condition that causes very high cholesterol levels from a young age. Participants will already be on a special diet and other cholesterol-lowering medicines. The study is comparing lerodalcibep to a dummy medicine (placebo) to see how well it lowers 'bad' cholesterol (LDL-C) and if it is safe. Researchers will check cholesterol levels, growth, and overall health to understand if this new medicine could be a helpful treatment for young people with HeFH.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

LIB Therapeutics Inc.

Enrolment target

Start

13 May 2026

Heterozygous Familial Hypercholesterolemia

What is this study about?

This study, called LIBerate-Kids, is looking into a new medicine called lerodalcibep for children and teenagers aged 6 to 17 who have a condition called Heterozygous Familial Hypercholesterolemia (HeFH). HeFH is a genetic condition where your body can't properly remove 'bad' cholesterol (LDL-C) from your blood, leading to very high levels even when you're young. This can increase the risk of heart problems later in life, so it's important to manage it.

The main goal of this study is to find out if lerodalcibep can effectively lower these high cholesterol levels in young people, and whether it's safe for them to use. Participants will be already managing their condition with a special diet and other medicines. Half of the participants will receive lerodalcibep, and the other half will receive a dummy medicine (placebo). This helps the researchers accurately see the effects of the new medicine.

Researchers will closely monitor changes in cholesterol levels, as well as checking on participants' growth, development, and overall health. This information will help doctors understand if lerodalcibep could be a valuable new treatment option to help young people with HeFH control their cholesterol and reduce future health risks.

Key takeaways

This study tests a new medicine called lerodalcibep for high cholesterol in children and teens aged 6-17 with HeFH.
It aims to see if lerodalcibep is effective at lowering 'bad' cholesterol and if it is safe.
Participants will receive either the study medicine or a dummy medicine (placebo).
Close monitoring of cholesterol levels, growth, and overall health will happen over around 6 months.
Taking part could mean access to a new treatment and helping future patients, but there are potential risks.

Who may be eligible?

This study is looking for children and teenagers who have a genetic condition called Heterozygous Familial Hypercholesterolemia (HeFH). This means you have inherited a gene that causes very high levels of 'bad' cholesterol (LDL-C) in your blood, even when you're young. If you're aged between 6 and 17 years old, you might be able to take part.

To join, you will already need to be following a special diet to help with your cholesterol and be taking other medicines that lower cholesterol. The study team will need to confirm your HeFH diagnosis and make sure your cholesterol levels meet certain criteria for the study.

There might be other health conditions or medicines that would mean you couldn't take part, as the researchers need to ensure the study is safe for everyone involved. The study doctor will go through all the details with you and your parents/guardians.

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 between 6 and 17 years old?
Do you have a diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)?
Are you currently following a special diet for cholesterol and taking other cholesterol-lowering medicines?
Is your HeFH diagnosis securely confirmed by a specialist?
Are you able to attend regular clinic appointments for about 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medicine, lerodalcibep, or a dummy medicine (placebo) as an injection. Both the medicine and the placebo will look the same, and neither you nor your doctor will know which you are receiving – this is standard practice in clinical trials. You'll continue to follow your special diet and take your other cholesterol-lowering medications as usual.

Throughout the study, you'll have regular visits to the clinic over about 24 weeks (around 6 months). At these visits, doctors will take blood samples to check your cholesterol levels and other markers, measure your height and weight, and assess your overall health and development. This includes checking things like your puberty stage and certain hormone levels. There will be other visits at specific times to monitor your progress and make sure you're doing well. After the 24 weeks, there might be some final follow-up appointments. The study team will explain the full schedule of visits and what each involves.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new medicine that might help manage your cholesterol condition, receiving close medical monitoring, and contributing to medical knowledge that could help others with HeFH in the future. However, there are also potential risks involved. The new medicine might have side effects, which the study team will carefully explain and monitor. You might also experience discomfort from blood tests or injections. You or your parents/guardians have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Norway

Common questions

What is Heterozygous Familial Hypercholesterolemia (HeFH)?

HeFH is a genetic condition where you inherit a gene from one parent that causes very high 'bad' cholesterol (LDL-C) levels from a young age, increasing the risk of heart disease.

What is lerodalcibep?

Lerodalcibep is a new medicine being tested to see if it can help lower 'bad' cholesterol levels in people with HeFH.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see the true effect of the new medicine.

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

No, neither you nor your study doctor will know whether you are receiving lerodalcibep or the placebo. This is to ensure the study results are as fair and accurate as possible.

How long will I be in the study?

The main part of the study where you receive the treatment will last for about 24 weeks, which is roughly 6 months. There may be some follow-up visits after this.