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Can a monthly shot keep Kids' inherited high cholesterol in check for years?

NCT ID NCT07775339

Disease control Sponsor: LIB Therapeutics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This trial is testing whether a monthly injection of lerodalcibep (Lerochol) can safely and effectively lower LDL cholesterol over three years in children and adolescents aged 6 to 17 with heterozygous familial hypercholesterolemia (HeFH), an inherited condition causing very high cholesterol. Participants, who have already completed an earlier 24-week study, will continue receiving 300 mg of lerodalcibep monthly via an auto-injector or pre-filled pen, alongside their usual diet and oral lipid-lowering medications. The study will track changes in LDL cholesterol and monitor safety through regular clinic visits, physical exams, blood tests, and heart checks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lerodalcibep (Lerochol), a monthly injection given under the skin
What this could lead to
If successful, this could offer a long-term, convenient monthly option to help children with inherited high cholesterol keep their LDL levels under control, potentially reducing future heart risks.
What could go wrong
This is an open-label extension study, so there is no placebo comparison, and long-term safety and effectiveness in children are still being confirmed. Possible side effects include injection-site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of written and signed informed consent/assent of the LIB003-016 trial prior to any study-specific procedure; 2. Completion of the LIB003-008 study having received the last dose of study drug at Week 20 and completed the Week 24 visit; 3. Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit of the LIB003-008 study; 4. Weight of \>18 kg (40 lbs) and BMI \<17 and \>42 kg/m2; 5. On stable diet and lipid-lowering oral drug therapy (statins, ezetimibe, bile-acid sequestrants) or combinations thereof (excluded oral lipid-lowering agents are include mipomersen, lomitapide, and gemfibrozil); Exclusion Criteria: 1. History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study; 2. Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception during the study and until 60 days after last dose of study drug, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit; 3. Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge; 4. A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history; 5. Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heterozygous familial hypercholesterolemia (HEFH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ege Universitesi Tip Fakultesi

    Izmir, Turkey (Türkiye)

  • G.B. Pant Institute of Postgraduate Medical Education & Research

    Delhi, 110002, India

  • Haddassah Medical Center

    Jerusalem, Israel

  • Iatros International

    Bloemfontein, Oranage Free State, South Africa

  • New Zealand Clinical Research

    Christchurch, New Zealand

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