Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
NCT ID: NCT04034485
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2019-12-07
2023-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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LIB003 (lerodalcibep)
300 mg SC Q4W
lerodalcibep
PCSK9 inhibitor
evolocumab
420 mg SC Q4W
evolocumab
PCSK9 inhibitor
Interventions
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lerodalcibep
PCSK9 inhibitor
evolocumab
PCSK9 inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
ALL
No
Sponsors
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LIB Therapeutics LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Evan A Stein, MD PhD
Role: STUDY_DIRECTOR
LIB Therapeutics
Locations
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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
CIMS Hospital Pvt. Ltd
Ahmedabad, , India
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, , India
Department of Medicine, Hadassah University Hospital
Jerusalem, , Israel
Rabin Medical Center, Beilinson Hospital,
Petah Tikva, , Israel
Lipid Clinic, Oslo University Hospital
Oslo, , Norway
Carbohydrate and Lipid Metabolism Research Unit
Johannesburg, Gauteng, South Africa
Division of Lipidology, Department of Medicine University of Cape Town
Cape Town, Western Province, South Africa
Ege University Medical School
Izmir, Bornova, Turkey (Türkiye)
Afyonkarahisar Health Sciences University
Afyonkarahisar, , Turkey (Türkiye)
Countries
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References
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Raal FJ, Mehta V, Kayikcioglu M, Blom D, Gupta P, Elis A, Turner T, Daniels C, Vest J, Mitchell T, Caldwell K, Bahassi EM, Kallend D, Stein EA. Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial. Lancet Diabetes Endocrinol. 2025 Mar;13(3):178-187. doi: 10.1016/S2213-8587(24)00313-9. Epub 2025 Jan 24.
Other Identifiers
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LIB003-003
Identifier Type: -
Identifier Source: org_study_id
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