Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction (LIBerate-CVD)
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ClinicalTrials.gov Identifier: NCT04797247 |
Recruitment Status :
Active, not recruiting
First Posted : March 15, 2021
Last Update Posted : December 11, 2023
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Sponsor:
LIB Therapeutics LLC
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
LIB Therapeutics LLC
Tracking Information | |||||
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First Submitted Date ICMJE | March 11, 2021 | ||||
First Posted Date ICMJE | March 15, 2021 | ||||
Last Update Posted Date | December 11, 2023 | ||||
Actual Study Start Date ICMJE | April 22, 2021 | ||||
Actual Primary Completion Date | November 15, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction | ||||
Official Title ICMJE | Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction | ||||
Brief Summary | This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy. | ||||
Detailed Description | Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration. Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 60 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to LIB003 or placebo. The total study duration will be up to 63 weeks which includes up to a Screening Period and 52 weeks of study drug treatment. Following randomization patients will be dosed and seen in the clinic Q4W (≤31 days). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double blind, placebo controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: participants, study staff, investigator and sponsor blinded to treatment and lipid levels Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Drug: lerodalcibep
PCSK9 inhibitor
Other Name: LIB003
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
900 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 28, 2024 | ||||
Actual Primary Completion Date | November 15, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04797247 | ||||
Other Study ID Numbers ICMJE | LIB003-005 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | LIB Therapeutics LLC | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | LIB Therapeutics LLC | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Medpace, Inc. | ||||
Investigators ICMJE |
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PRS Account | LIB Therapeutics LLC | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |