An open label extension study to evaluate the long term efficacy and safety of LIB-003 in patients with familial hypercholesterolemia, very high or high risk for cardiovascular disease who are on stable lipid-lowering therapy requiring additional LDL-C reduction (LIBerate-OLE).

Phase 3

• Conditions: Health Condition 1: E783- Hyperchylomicronemia

• Registration Number: CTRI/2021/11/037835
• Lead Sponsor: IB Therapeutics LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. 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

2.Provision of written and signed informed consent prior to any study-specific procedure;

3. 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;

4. 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

5. Patient is considered by the Investigator to be otherwise healthy,

Exclusion Criteria

1. 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;

2. 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 Investigaton

Study & Design

• Study Type: Interventional
• Study Design: Not specified