Enrolling by invitation
Phase 3
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Condition(s) studied
Cardiovascular Disease With Mention of ArteriosclerosisElevated CholesterolFamilial Hypercholesterolemia
Investigational drug(s) / intervention(s)
lerodalcibep
lerodalcibep: PCSK9 inhibitor
Study 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.
Eligibility
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
* 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,
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;
* 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;
Primary outcome measure(s)
- 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
Evaluation of Adverse Events based on MedRA based on ITT population
Trial sites (12)
| Facility | City | Region | Status |
| NorthShore University Health System |
Evanston |
Illinois |
|
| Sterling Research Group |
Cincinnati |
Ohio |
|
| The Lindner Research Center |
Cincinnati |
Ohio |
|
| Metabolic & Atherosclerosis Research Center (MARC) |
Cincinnati |
Ohio |
|
| 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 |
|
| Division of Lipidology, Department of Medicine University of Cape Town |
Cape Town |
Western Province |
|
| Ege University Medical School |
Izmir |
Bornova |
|
| Afyonkarahisar Health Sciences University |
Afyonkarahisar |
Turkey (Türkiye) |
|