Status:
ENROLLING_BY_INVITATION
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Lead Sponsor:
LIB Therapeutics LLC
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Cardiovascular Disease With Mention of Arteriosclerosis
Elevated Cholesterol
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief Summary
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with C...
Detailed Description
The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB...
Eligibility Criteria
Inclusion
- Successful completion 1 of one of the Phase 3 base studies LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to LIB003; or
- Provision of written and signed informed consent prior to any study-specific procedure;
- Female patients of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing;
- Patient is willing to maintain appropriate diet and stable dose of current lipid-lowering therapy including statins, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and
- Patient is considered by the Investigator to be otherwise healthy,
Exclusion
- Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to study drug during the base Phase 3 study;
- Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator,
- Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months;
- Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
- Has any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04798430
Start Date
December 3 2020
End Date
December 31 2025
Last Update
October 22 2024
Active Locations (12)
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1
NorthShore University Health System
Evanston, Illinois, United States, 60201
2
Sterling Research Group
Cincinnati, Ohio, United States, 45219
3
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
4
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227