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

ConditionHeterozygous Familial Hypercholesterolemia (HeFH)

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age6-17

SponsorLIB Therapeutics LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;

A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;

Trial design

Design model

Single group

Treatments tested in this trial

Lerodalcibep
Drug
300 mg monthly

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: LerodalcibepExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LIB Therapeutics LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: