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Study identifier: NCT07102511 Synced from ClinicalTrials.gov · August 05, 2026
● Enrolling By Invitation

Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH

Condition: Familial Hypercholesterolemia - Heterozygous  ·  Sponsor: LIB Therapeutics LLC

PhasePhase 3
Planned participants150
Who can joinAll sexes, 6 Years to 17 Years
Healthy volunteersNo

About this study

The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP) compared to placebo (dummy), 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. The main question\[s\] it aims to answer are: How effective is Lerochol in reducing LDL cholesterol? How well is it tolerated and are there any safety concerns? Researchers will compare Lerochol to placebo (inert or dummy injection solution). Participants will visit the clinic every month for months and be asked to fast overnight, but allowed to drink water, before clinic visits. Undergo 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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (7)

Metabolic & Atherosclerosis Research CenterCincinnati, Ohio, United States
Lipid Clinic Hadassah Medical CenterJerusalem, Israel
New Zealand Clinical ResearchChristchurch, New Zealand
The Lipid Clinic Oslo University HospitalOslo, Norway
Iatros InternationalBloemfontein, Free State, South Africa
Lipid Clinic Wits UniversityJohannesburg, Gauteng, South Africa
Ege Universitesi Tip FakultesiIzmir, Turkey (Türkiye)

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