A Phase 3 interventional study of Lerodalcibep in Heterozygous Familial Hypercholesterolemia (HeFH), sponsored by LIB Therapeutics LLC. Not yet recruiting at 5 sites in 5 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by LIB Therapeutics LLC · Phase 3, Interventional, and Treatment
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.
STUDY DESIGN AND DURATION:
This is an open label Phase 3b study to evaluate the long-term efficacy, safety, and tolerability of lerodalcibep 300 mg administered SC QM (\<31 days) over a 156-week Treatment Period. Approximately 150 males and females 6 to 17 years of age at time of entry in the base LIB003 008 study, with HeFH and who completed the LIB003-008 study at approximately 30 sites in the United States, Canada, Central and South America, Europe, South Africa, Asia, Australasia, and the Middle East may be eligible to continue into this 156-week long term open-label extension with lerodalcibep after signing an independent informed consent form.
Patients maintaining their statin with or without ezetimibe and other allowed oral LDL-C-lowering agents will be eligible.
Study Procedures Patients who meet all eligibility criteria for the LIB003-016 study may proceed directly to the first dose of lerodalcibep at the final visit of the LIB003-008 study. Patients will receive SC doses, via auto-injector (AI)/prefilled pen (PFP) of lerodalcibep 300 mg QM (31 days) until Week 152. Following administration of the last dose at Week 152, the patients will return 4 weeks later for follow-up at Week 156.
Patients may begin the OLE on the final visit of their prior study and/or have up to 28 days to return for Day 1 of the OLE. The period between the base study and LIB003-008 may be extended upon review and approval.
Patients will be able to be dosed at home between clinic visits. In addition to a basic lipid profile, LDL-C will be measured by PUC at specified visits during the study. Safety assessments will include adverse events (AEs) and the results from physical examinations, including Tanner staging, skin and Achilles/extensor tendon xanthoma, electrocardiograms (ECGs), and clinical laboratory tests (hematology, serum safety chemistry, and urinalysis). Tests for growth and development (eg, estradiol, testosterone, dehydroepiandrosterone, follicle stimulating hormone, luteinizing hormone, adrenocorticotropic hormone, and cortisol) will be assessed at the Week 48, 96 and 156 visits. Samples will be collected for immunogenicity testing. Injection site reactions will be assessed at each dosing visit.
249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.
This study's planned enrollment of 150 is above the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →LIB Therapeutics LLC is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
lerodalcibep 300 mg monthly
Drug: Lerodalcibep
300 mg monthly
Change in LDL cholesterol at Week 156 from baseline
The primary objective of this study is to assess the change in LDL-C (by Friedewald Formula) at Week 156 with monthly lerodalcibep 300 mg QM
Time frame: 156 weeks
Plan to share: Undecided
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lerodalcibep
Hyperlipoproteinemia Type II →
LIB Therapeutics LLC