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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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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.
The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012). Patients will continue to maintain their existing oral lipid-lowering therapy (LLT).
Following completion of a base study and providing informed consent, patients will receive doses of LIB003 300 mg Q4W (<31 days) on Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68. Patients will be seen in the clinic Q4W (<31 days) for at least the initial 12 weeks and then every 12 weeks (Weeks 24, 36, 48, 60, and 72) with the interim Q4W (<31 days) doses administered at home.
Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial. Their lipids will remain blinded (to patient, study staff and sponsor) until week 4 to avoid any unblinding of the prior trial. Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIB003 (lerodalcibep) | Experimental | 300 mg monthly (Q4W) by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lerodalcibep | Drug | PCSK9 inhibitor |
|
|
| Measure | Description | 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 weeks | Evaluation of Adverse Events based on MedRA based on ITT population | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Incidence of anti-drug antibodies | 72 weeks |
| LDL Cholesterol reduction | Percent decrease in LDL-C from baseline of original study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kallend, MB BCh | LIB Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | 60201 | United States | ||
| Sterling Research Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42054033 | Derived | Raal FJ, Fourie N, Scott R, Blom DJ, Basson MMV, Kayikcioglu M, Roth M, Vest J, Kallend D, Stein EA. Response to PCSK9 Inhibition Based on LDL Receptor Function in Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):593-598. doi: 10.1001/jamacardio.2026.0879. |
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open label extension trial
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lipids blinded to participant, investigator and sponsor at Day 1 only
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| 72 weeks |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| The Lindner Research Center | Cincinnati | Ohio | 45219 | United States |
| Metabolic & Atherosclerosis Research Center (MARC) | Cincinnati | Ohio | 45227 | United States |
| G.B. Pant Institute of Postgraduate Medical Education & Research | New Delhi | 110002 | India |
| Department of Medicine, Hadassah University Hospital | Jerusalem | 12000 | Israel |
| Rabin Medical Center, Beilinson Hospital, | Petah Tikva | 49100 | Israel |
| Lipid Clinic, Oslo University Hospital | Oslo | 0586 | Norway |
| Carbohydrate and Lipid Metabolism Research Unit | Johannesburg | Gauteng | 2193 | South Africa |
| Division of Lipidology, Department of Medicine University of Cape Town | Cape Town | Western Province | 7925 | South Africa |
| Ege University Medical School | Izmir | Bornova | 35040 | Turkey (Türkiye) |
| Afyonkarahisar Health Sciences University | Afyonkarahisar | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
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