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Clinical Trials in India / NCT07775339
Starting soon Phase 3

Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia

NCT07775339 · tracked via the Priya Life Science India tracker
Sponsor
LIB Therapeutics LLC
Phase
Phase 3
Started
2027-01-20
Last updated
2026-08-25

Condition(s) studied

Heterozygous Familial Hypercholesterolemia (HeFH)

Investigational drug(s) / intervention(s)

Lerodalcibep

Lerodalcibep: 300 mg monthly

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
G.B. Pant Institute of Postgraduate Medical Education & Research Delhi India
Haddassah Medical Center Jerusalem Israel
New Zealand Clinical Research Christchurch New Zealand
Iatros International Bloemfontein Oranage Free State
Ege Universitesi Tip Fakultesi Izmir Turkey (Türkiye)

More LIB Therapeutics LLC trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07775339 on ClinicalTrials.gov ↗ ← All trials in India