Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04806893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2021-03-16
Brief Title:
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
Sponsor:
LIB Therapeutics LLC
Organization:
LIB Therapeutics LLC
Study Overview
Official Title:
Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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-HR
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 CVD or at 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 65 sites in the United States Canada Europe South Africa Asia Australasia and the Middle East Patients will be randomized in a 21 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
Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 65 sites in the United States Canada Europe South Africa Asia Australasia and the Middle East Patients will be randomized in a 21 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
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