NCT07775339Not yet recruitingPhase 3
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia
Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia (LIBerate-Kids OLE)
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)/pre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial. The main question\[s\] it aims to answer are: How effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns? Participants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 16 Aug 2026
- Start date
- 20 Jan 2027
- Primary completion date
- 31 Jul 2031
- Lead sponsor
- LIB Therapeutics LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07775339
- EU CT number
- 2026-528022-38-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 20 Jan 2027 to the primary completion date, 31 Jul 2031
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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;
- A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;
Other
- Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
- Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;
Who the study is looking for
- Provision of written and signed informed consent/assent of the LIB003-016 trial prior to any study-specific procedure;
- Completion of the LIB003-008 study having received the last dose of study drug at Week 20 and completed the Week 24 visit;
- 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;
- Weight of \>18 kg (40 lbs) and BMI \<17 and \>42 kg/m2;
- 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);
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haddassah Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| G.B. Pant Institute of Postgraduate Medical Education & Research Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| IATROS International Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Ege Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.