lerodalcibep
Sponsors
Lib Therapeutics LLC, LIB Therapeutics Inc., LIB Therapeutics LLC, Hasten Biopharmaceutical Co., Ltd., Sponsor LIB Therapeutics Inc
Conditions
ASCVDAtherosclerotic Ischemic DiseaseCardiovascular DiseaseCardiovascular Disease With Mention of ArteriosclerosisCardiovascular DiseasesCardiovascular Risk FactorCardiovascular StrokeDyslipidemias
Phase 3
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
CompletedNCT04034485
Start: 2019-12-07End: 2023-01-30Updated: 2023-03-29
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
CompletedNCT04790513
Start: 2021-04-22End: 2022-12-31Updated: 2023-03-29
Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction
NCT04797247
Start: 2021-04-22End: 2024-02-28Target: 900Updated: 2023-12-11
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Enrolling by invitationNCT04798430
Start: 2020-12-03End: 2025-12-31Target: 2000Updated: 2024-10-22
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
CompletedNCT04797104
Start: 2021-04-22End: 2023-12-05Updated: 2023-12-11
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
NCT04806893
Start: 2021-04-22End: 2024-02-28Target: 900Updated: 2023-12-11
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
CompletedNCT05004675
Start: 2022-06-20End: 2024-10-15Updated: 2024-10-23
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
CompletedNCT05234775
Start: 2022-01-28End: 2022-07-11Updated: 2022-07-14
Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)
CompletedCTIS2023-510057-41-00
Start: 2021-10-06End: 2025-08-19Target: 590Updated: 2025-04-02
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
RecruitingNCT06568471
Start: 2024-11-16End: 2026-05-31Target: 210Updated: 2025-02-06
Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, with Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids)
Not yet recruitingCTIS2025-524214-28-00
Target: 5Updated: 2026-05-13
Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
Active, not recruitingPACTR202605715221380
Start: 2026-07-01Target: 50Updated: 2026-09-14
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia
Not yet recruitingNCT07775339
Start: 2027-01-20End: 2031-12-31Target: 150Updated: 2026-08-25