Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

LIB Therapeutics

Status and phase

Completed

Phase 3

Conditions

Homozygous Familial Hypercholesterolemia

Treatments

Drug: lerodalcibep

Drug: evolocumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04034485

LIB003-003

Details and patient eligibility

About

To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy

Full description

Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B).

Enrollment

65 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HoFH diagnosed clinically and confirmed by genotyping
Weight of >30 kg and body mass index (BMI) >17 and <40 kg/m2
stable diet and lipid-lowering oral therapies for at least 4 weeks

Exclusion criteria

mipomersen within 6 months of screening;
LDL or plasma apheresis <2 months prior to randomization
history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR activity expected to result in non-response to PCSK9 inhibition
prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion