Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

Enrolling by invitation · Phase 3

Conditions studied: Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID: NCT04798430
Run by: LIB Therapeutics LLC
People needed: 2000
Starts: 2020-12-03
Expected to finish: 2025-12-31
Last updated by the study team: 2024-10-22

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Provision of written and signed informed consent prior to any study-specific procedure;
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;
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
Patient is considered by the Investigator to be otherwise healthy,

You may not qualify if…

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;
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 Investigator,
Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months;
Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
Has any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;

Where it is running

NorthShore University Health System — Evanston, Illinois, United States
Sterling Research Group — Cincinnati, Ohio, United States
The Lindner Research Center — Cincinnati, Ohio, United States
Metabolic & Atherosclerosis Research Center (MARC) — Cincinnati, Ohio, United States
G.B. Pant Institute of Postgraduate Medical Education & Research — New Delhi, India
Department of Medicine, Hadassah University Hospital — Jerusalem, Israel
Rabin Medical Center, Beilinson Hospital, — Petah Tikva, Israel
Lipid Clinic, Oslo University Hospital — Oslo, Norway
Carbohydrate and Lipid Metabolism Research Unit — Johannesburg, Gauteng, South Africa
Division of Lipidology, Department of Medicine University of Cape Town — Cape Town, Western Province, South Africa
Ege University Medical School — Izmir, Bornova, Turkey (Türkiye)
Afyonkarahisar Health Sciences University — Afyonkarahisar, Turkey (Türkiye)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.