Lerodalcibep for Children with Heterozygous Familial Hypercholesterolemia

This study is testing a medicine called lerodalcibep (300 mg given monthly as a shot under the skin) in children aged 6 to 17 years who have heterozygous familial hypercholesterolemia (HeFH), an inherited condition causing very high cholesterol. The main goal is to see how well lerodalcibep lowers "bad" cholesterol (LDL-C) after 12 weeks, compared to a dummy shot (placebo). Researchers also want to understand if it's safe and how well children tolerate it. You might be able to join if you are 6 to 17 years old, weigh over 40 lbs, and have HeFH while already taking cholesterol-lowering medicines like statins. The study is currently recruiting about 150 participants.

Study design
This is a randomized, placebo-controlled, double-blind study, meaning participants are randomly assigned to receive either lerodalcibep or a placebo, and neither you nor your doctor will know which you are receiving. Approximately 150 participants will be enrolled.
What's involved
The total study duration will be up to 35 weeks, including a screening period of up to 11 weeks and 24 weeks of treatment. You will have clinic visits monthly for 20 weeks, then at weeks 22 and 24.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring LDL cholesterol is at Week 12, and the treatment period lasts 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07102511

Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH

Enrolling by Invitation
PHASE3Ages 6–17InterventionalTreatment
LIB Therapeutics LLC
~150 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:lerodalcibep 300 mg Monthly SC

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Low Density Lipoprotein cholesterol at week 12
Measured over Week 12
Familial Hypercholesterolemia - Heterozygous

NCT07102511

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ege Universitesi Tip Fakultesi

    Izmir, Turkey (Türkiye)no site contact published

  • Iatros International

    Bloemfontein, Free State, South Africano site contact published

  • Lipid Clinic Hadassah Medical Center

    Jerusalem, Israelno site contact published

  • Lipid Clinic Wits University

    Johannesburg, Gauteng, South Africano site contact published

  • Metabolic & Atherosclerosis Research Center

    Cincinnati, Ohiono site contact published

  • New Zealand Clinical Research

    Christchurch, New Zealandno site contact published

  • The Lipid Clinic Oslo University Hospital

    Oslo, Norwayno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • David Kallend, MB BS · STUDY_DIRECTOR · Chief Medical Officer, LIB Therapeutics, LLC

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Low Density Lipoprotein cholesterol at week 12Week 12

    Change in LDL-C at week 12 relative to that of placebo