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

Sponsor
LIB Therapeutics LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04034485
Collaborator
(none)
70
Enrollment
12
Locations
2
Arms
33.8
Anticipated Duration (Months)
5.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
open label, randomized, cross-overopen label, randomized, cross-over
Masking:
None (Open Label)
Masking Description:
treatment is open label but lipid results are masked to participant, investigator and sponsor
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Dec 7, 2019
Anticipated Primary Completion Date :
Aug 12, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LIB003 (lerodalcibep)

300 mg SC Q4W

Drug: lerodalcibep
PCSK9 inhibitor
Other Names:
  • LIB003

    		•
    Active Comparator: evolocumab

    420 mg SC Q4W

    Drug: evolocumab
    PCSK9 inhibitor
    Other Names:
  • Repatha

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24 [baseline to 24 weeks on each treatment]

      Change in serum LDL-C from baseline after 24 weeks

    Secondary Outcome Measures

    1. The incidence and severity of treatment emergent adverse events (TEAEs) [baseline to 24 weeks on each treatment]

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

    Other Outcome Measures

    1. Percent reduction in lipoprotein (a) [Lp(a)] at week 24 [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 [baseline to 24 weeks on each treatment]

      Change in serum Apo B from baseline after 24 weeks

    3. Presence of anti LIB003 antibodies (ADAs) [baseline to 24 weeks]

      Measurement of ADAs at baseline and various intervals

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NorthShore University Health System Evanston Illinois United States 60201
    2 Metabolic & Atherosclerosis Research Center (MARC) Cincinnati Ohio United States 45227
    3 VMMC & Safdarjung Hospital Delhi NCT India
    4 CIMS Hospital Pvt. Ltd Ahmedabad India
    5 G.B. Pant Institute of Postgraduate Medical Education & Research New Delhi India 110002
    6 Department of Medicine, Hadassah University Hospital Jerusalem Israel 12000
    7 Rabin Medical Center, Beilinson Hospital, Petah Tikva Israel 49100
    8 Lipid Clinic, Oslo University Hospital Oslo Norway 0586
    9 Carbohydrate and Lipid Metabolism Research Unit Johannesburg Gauteng South Africa 2193
    10 Division of Lipidology, Department of Medicine University of Cape Town Cape Town Western Province South Africa 7925
    11 Ege University Medical School İzmir Bornova Turkey 35040
    12 Afyonkarahisar Health Sciences University Afyon Turkey

    Sponsors and Collaborators

    • LIB Therapeutics LLC

    Investigators

    • Study Director: Evan A Stein, MD PhD, LIB Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LIB Therapeutics LLC
    ClinicalTrials.gov Identifier:
    NCT04034485
    Other Study ID Numbers:
    • LIB003-003
    First Posted:
    Jul 26, 2019
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LIB Therapeutics LLC
    LDL cholesterol
    PCSK9 inhibition
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hypercholesterolemia
    Evolocumab

    Study Results

    No Results Posted as of Jul 14, 2022