8 completed, 2 enrolling by invitation, 2 unknown, 1 not yet recruiting. 10 Phase 3, 2 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 5, Enrolling by invitation 2, Unknown 2, Not yet recruiting 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia Lerodalcibep - Heterozygous Familial Hypercholesterolemia (HeFH) | Phase 3 | Not yet recruiting | LIB Therapeutics LLC | 150 | 2027-01-20 | 2026-08-25 |
| Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH lerodalcibep 300 mg Monthly SC - Familial Hypercholesterolemia - Heterozygous | Phase 3 | Enrolling by invitation | LIB Therapeutics LLC | 150 | 2026-07-20 | 2026-07-28 |
| Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients lerodalcibep, Inclisiran - Hypercholesterolemia, Atherosclerotic Ischemic Disease | Phase 3 | Completed | LIB Therapeutics LLC | 166 | 2022-06-20 | 2024-10-23 |
| Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product lerodalcibep - Hypercholesterolemia | Phase 3 | Completed | LIB Therapeutics LLC | 22 | 2022-01-28 | 2022-07-14 |
| Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients lerodalcibep, evolocumab, alirocumab - Hypercholesterolemia, Cardiovascular Diseases | Phase 3 | Completed | LIB Therapeutics LLC | 204 | 2021-04-22 | 2023-03-29 |
| Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction lerodalcibep, Placebo - Cardiovascular Risk Factor, Cardiovascular Diseases | Phase 3 | Unknown | LIB Therapeutics LLC | 900 | 2021-04-22 | 2023-12-11 |
| Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction lerodalcibep - Cardiovascular Diseases, Hyper-LDL-cholesterolemia | Phase 3 | Unknown | LIB Therapeutics LLC | 900 | 2021-04-22 | 2023-12-11 |
| Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction lerodalcibep - Heterozygous Familial Hypercholesterolemia | Phase 3 | Completed | LIB Therapeutics LLC | 478 | 2021-04-22 | 2026-10-27 |
| Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction lerodalcibep - Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol | Phase 3 | Enrolling by invitation | LIB Therapeutics LLC | 2000 | 2020-12-03 | 2024-10-22 |
| Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH lerodalcibep, evolocumab - Homozygous Familial Hypercholesterolemia | Phase 3 | Completed | LIB Therapeutics LLC | 65 | 2019-12-07 | 2023-03-29 |
| Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 LIB003 - Hypercholesterolemia | Phase 2 | Completed | LIB Therapeutics LLC | 32 | 2019-02-14 | 2022-03-02 |
| Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction LIB003 - LDL Cholesterol | Phase 2 | Completed | LIB Therapeutics LLC | 81 | 2018-05-22 | 2019-02-18 |
| Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003 LIB003 - Hypercholesterolemia | Phase 1 | Completed | LIB Therapeutics LLC | 63 | 2017-10-30 | 2018-07-27 |
Hypercholesterolemia (8) · Cardiovascular Diseases (3) · Homozygous Familial Hypercholesterolemia (1) · Hyperlipoproteinemia Type II (1) · Myocardial Infarction (1)
evolocumab (2) · ALN-PCS (1) · alirocumab (1)
United States (11) · Israel (6) · Norway (5) · South Africa (5) · Turkey (Türkiye) (5) · India (4) · New Zealand (2) · France (1) · Germany (1) · Spain (1) · United Kingdom (1)
Evan A Stein, MD PhD (6) · David Kallend, MB BCh (2) · Traci A Turner, MD (2) · David Kallend, MB BS (1) · Evan A Stein, MD (1)
PMID 38958989, PMID 39870096, PMID 42054033
2025 (1)