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.
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
At a glance
Conditions
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.
Study leadership
- David Kallend, MB BS · STUDY_DIRECTOR · Chief Medical Officer, LIB Therapeutics, LLC
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Low Density Lipoprotein cholesterol at week 12Week 12
Change in LDL-C at week 12 relative to that of placebo