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Lerodalcibep

Phase 3

Heterozygous Familial Hypercholesterolemia (HeFH) | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Aug 25, 2026

Target and mechanism

Molecular targetPCSK9
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Lerodalcibep · 1 trial · 1 indication

Phase 3 1
NCT07775339Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial HypercholesterolemiaHeterozygous Familial Hypercholesterolemia (HeFH)
NOT YET_RECRUITING150 Analytics
PHASE3NOT YET_RECRUITING
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia (HeFH)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in LDL cholesterol at Week 156 from baseline
156 weeks

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

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LerodalcibepEXPERIMENTALlerodalcibep 300 mg monthly

Interventions

NameTypeDescription
LerodalcibepDRUG300 mg monthly
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 year...

Countries:IndiaIsraelNew ZealandSouth AfricaTurkey (Türkiye)
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