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

LIB Therapeutics LLC65 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

lerodalcibepDRUG

PCSK9 inhibitor

evolocumabDRUG

PCSK9 inhibitor

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (12)

NorthShore University Health System

Evanston, Illinois, United States

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, United States

VMMC & Safdarjung Hospital

Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24

Change in serum LDL-C from baseline after 24 weeks

Time frame: baseline to 24 weeks on each treatment

Secondary Outcomes

The incidence and severity of treatment emergent adverse events (TEAEs)

safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Time frame: baseline to 24 weeks on each treatment

Data from ClinicalTrials.gov

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