Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798430
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-03-29
First Post:
2021-03-09
Brief Title:
Long-term Efficacy and Safety of OLE LIB003 in HoFH HeFH and High-risk CVD Patients Requiring Further LDL-C Reduction
Sponsor:
LIB Therapeutics LLC
Organization:
LIB Therapeutics LLC
Study Overview
Official Title:
Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH CVD or at High Risk for CVD on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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-OLE
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 CVD or at high risk for CVD including HoFH and HeFH on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies
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 LIB003-005 LIB003-006 LIB003-008 LIB003-011 and LIB003-012 Patients will continue to maintain their existing oral lipid-lowering therapy LLT
Following completion of a base study and providing informed consent patients will receive doses of LIB003 300 mg Q4W 31 days on Day 1 and Weeks 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 and 68 Patients will be seen in the clinic Q4W 31 days for at least the initial 12 weeks and then every 12 weeks Weeks 24 36 48 60 and 72 with the interim Q4W 31 days doses administered at home
Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial Their lipids will remain blinded to patient study staff and sponsor until week 4 to avoid any unblinding of the prior trial Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial
Following completion of a base study and providing informed consent patients will receive doses of LIB003 300 mg Q4W 31 days on Day 1 and Weeks 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 and 68 Patients will be seen in the clinic Q4W 31 days for at least the initial 12 weeks and then every 12 weeks Weeks 24 36 48 60 and 72 with the interim Q4W 31 days doses administered at home
Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial Their lipids will remain blinded to patient study staff and sponsor until week 4 to avoid any unblinding of the prior trial Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial
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