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lerodalcibep Monthly

Phase 3

Familial Hypercholesterolemia - Heterozygous | Monoclonal antibody | Metabolic |Medpace Holdings, Inc. Common Stock|Last Updated: Jul 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

lerodalcibep Monthly · 1 trial · 1 indication

Phase 3 1
NCT07102511Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FHFamilial Hypercholesterolemia - Heterozygous
ENROLLING BY_INVITATION150 Analytics
PHASE3ENROLLING BY_INVITATION
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
Familial Hypercholesterolemia - Heterozygous
NCT07102511150
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Study Endpoints

Primary Endpoints

Low Density Lipoprotein cholesterol at week 12
Week 12

Change in LDL-C at week 12 relative to that of placebo

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LerodalcibepACTIVE_COMPARATOR300 mg SC QM
PlaceboPLACEBO_COMPARATORSC QM

Interventions

NameTypeDescription
lerodalcibep 300 mg Monthly SCBIOLOGICALlerodalcibep or placebo
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Provision of written and signed informed consent/assent prior to any study-specific procedure; 2. 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; 3. Weight of more than 18 kg (40 lbs) and BMI more than 17 an...

Countries:United StatesIsraelNew ZealandNorwaySouth AfricaTurkey (Türkiye)
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