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

Recruiting

• Conditions: Hyperchylomicronemia,

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

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

Not available

Study Timeline

• Study Start: 2022-06-04
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 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

• 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

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks	72 weeks

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	LDL Cholesterol reduction

Trial Locations

Locations (7)

Care Institute of Medical Sciences; 🇮🇳 Ahmadabad, GUJARAT, India

Department of Cardiology; 🇮🇳 Delhi, DELHI, India

G .B. Pant Institute of Postgraduate Medical Education & Research; 🇮🇳 Delhi, DELHI, India

Indraprastha Apollo Hospital; 🇮🇳 Delhi, DELHI, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital; 🇮🇳 Delhi, DELHI, India

Care Institute of Medical Sciences

🇮🇳Ahmadabad, GUJARAT, India

Dr Milan Chinubhai Chag

Principal investigator

7930101166

milan.chag@cims.me