Status:
COMPLETED
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
Lead Sponsor:
LIB Therapeutics LLC
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
10+ years
Phase:
PHASE3
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 (Re...
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, s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04034485
Start Date
December 7 2019
End Date
January 30 2023
Last Update
March 29 2023
Active Locations (12)
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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, National Capital Territory of Delhi, India
4
CIMS Hospital Pvt. Ltd
Ahmedabad, India