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Completed

NCT Number: NCT04034485

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

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

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Key information

Conditions

Homozygous Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VMMC & Safdarjung Hospital, Delhi, National Capital Territory of Delhi, India

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lerodalcibep

Drug

PCSK9 inhibitor

Other names: LIB003

Evolocumab

Drug

PCSK9 inhibitor

Other names: Repatha

Primary outcomes

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

    Time frame: baseline to 24 weeks on each treatment

    Change in serum LDL-C from baseline after 24 weeks

Secondary outcomes

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

    Time frame: baseline to 24 weeks on each treatment

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

Other outcomes

  1. Percent reduction in lipoprotein (a) [Lp(a)] at week 24

    Time frame: baseline to 24 weeks on each treatment

    Change in serum Lp(a) from baseline after 24 weeks

  2. Percent reduction in apolipoprotein B (Apo B) at week 24

    Time frame: baseline to 24 weeks on each treatment

    Change in serum Apo B from baseline after 24 weeks

  3. Presence of anti LIB003 antibodies (ADAs)

    Time frame: baseline to 24 weeks

    Measurement of ADAs at baseline and various intervals

Sponsors and collaborators

Lead sponsor

LIB Therapeutics LLC

Industry

Registry information

Official study title

Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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