Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04790513
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2021-03-06
Brief Title:
Trial to Evaluate Efficacy and Safety of LIB003 Evolocumab and Alirocumab in High-risk CVD Patients
Sponsor:
LIB Therapeutics LLC
Organization:
LIB Therapeutics LLC
Study Overview
Official Title:
Randomized Open-label Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 Evolocumab and Alirocumab in CVD Patients or at High Risk for CVD on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction LIBerate-H2H
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIBerate-H2H
Brief Summary:
Comparison of LDL-C reductions at Week 12 of monthly Q4W 31 days dosing of LIB003 300 mg administered subcutaneously SC to Q4W dosing of evolocumab Repatha 420 mg and alirocumab Praluent 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy
Detailed Description:
This is a randomized open-label Phase 3 study of 12 weeks duration comparing Q4W SC doses of LIB003 300 mg evolocumab Repatha 420 mg and alirocumab Praluent 300 mg Approximately 220 males and females aged 18 years who fulfill all of the inclusion and exclusion criteria will be enrolled at up to 25 sites in the United States Patients will be stratified by baseline LDL-C and randomized in a 221 ratio to LIB003 88 patients Repatha 88 patients or Praluent 44 patients administered SC Q4W 31 days The study will consist of a Screening Period and a Treatment Period The total study duration will be up to 21 weeks which includes up to 9-week Screening Period depending on period required for washout of PCSK9 mAb andor intensification of statin treatment and 12 weeks of study drug treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None