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).

Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/037835

Enrollment

2000

Registered

2021-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E783- Hyperchylomicronemia

Interventions

Intervention1: LIB003: SC injection in either the abdomen, thigh or upper arm (which may be rotated) on Week 0 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68 Control In

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeksTimepoint: 72 weeks	—

Secondary

Measure	Time frame
Immunogenicity LDL Cholesterol reductionTimepoint: 72 weeks 72 weeks	—

Countries

Canada, France, Germany, India, Israel, New Zealand, Norway, South Africa, Spain, Turkey, United Kingdom, United States of America

Contacts

Public ContactJyoti Kulaye

G .B. Pant Institute of Postgraduate Medical Education & Research,

drvimalmehta@yahoo.co.in9718599105

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026