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- LIB003 / LIB Therap
[VIRTUAL] EFFICACY AND SAFETY OF A 52 WEEK OPEN LABEL PHASE 2B EXTENSION TRIAL WITH MONTHLY DOSING OF AN ANTI-PCSK9 SMALL BINDING PROTEIN (eAbstract Virtual Hall) - Dec 22, 2019 - Abstract #ACC2020ACC_6271;
LIB 300 mg dosed QM in 1.2 mL was well tolerated, safe and provided sustained PCSK9 with LDL-C reductions >60%. In 1 patient ADAs exceeded the level of assay sensitivity recommended by FDA with no impact on efficacy
- | lerodalcibep (LIB003) / LIB Therap
Enrollment closed, Trial completion date, Trial primary completion date: Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 (clinicaltrials.gov) - Nov 15, 2019
P2b, N=32, Active, not recruiting, Sponsor: LIB Therapeutics LLC
In 1 patient ADAs exceeded the level of assay sensitivity recommended by FDA with no impact on efficacy Enrolling by invitation --> Active, not recruiting | Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Oct 2019 --> Mar 2020
- |||| lerodalcibep (LIB003) / LIB Therap
Enrollment open: Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH (clinicaltrials.gov) - Nov 8, 2019
P3, N=70, Enrolling by invitation, Sponsor: LIB Therapeutics LLC
Enrolling by invitation --> Active, not recruiting | Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Oct 2019 --> Mar 2020 Not yet recruiting --> Enrolling by invitation
- LIB003 / LIB Therap
Safety, Tolerability and LDL-C Reduction With LIB003 a Novel Anti-PCSK9 Recombinant Fusion Protein: Results of Open-Label Extension Phase 2B Study (126B) - Aug 21, 2019 - Abstract #AHA2019AHA_7714;
Not yet recruiting --> Enrolling by invitation LIB at 300 mg (1.2 mL) Q4W achieved maximal, stable mean (95% CI) reductions in LDL-C of approximately 60% from baseline through the study period (p<0.0001) and was well tolerated
- | lerodalcibep (LIB003) / LIB Therap
New P3 trial: Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH (clinicaltrials.gov) - Jul 25, 2019
P3, N=70, Not yet recruiting, Sponsor: LIB Therapeutics LLC
- ||| lerodalcibep (LIB003) / LIB Therap
New P2b trial: Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 (clinicaltrials.gov) - Feb 20, 2019
P2b, N=40, Enrolling by invitation, Sponsor: LIB Therapeutics LLC
- ||| lerodalcibep (LIB003) / LIB Therap
Trial completion: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction (clinicaltrials.gov) - Feb 18, 2019
P2, N=81, Completed, Sponsor: LIB Therapeutics LLC
LIB at 300 mg (1.2 mL) Q4W achieved maximal, stable mean (95% CI) reductions in LDL-C of approximately 60% from baseline through the study period (p<0.0001) and was well tolerated Active, not recruiting --> Completed
- | lerodalcibep (LIB003) / LIB Therap
Trial completion: LIB003SAD: Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003 (clinicaltrials.gov) - Jul 27, 2018
P1, N=63, Completed, Sponsor: LIB Therapeutics LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| lerodalcibep (LIB003) / LIB Therap
New P1 trial: LIB003SAD: Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003 (clinicaltrials.gov) - Jul 15, 2018
P1, N=63, Active, not recruiting, Sponsor: LIB Therapeutics LLC
- || lerodalcibep (LIB003) / LIB Therap
Enrollment closed: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction (clinicaltrials.gov) - Jul 3, 2018
P2, N=80, Active, not recruiting, Sponsor: LIB Therapeutics LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| lerodalcibep (LIB003) / LIB Therap
New P2 trial: Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction (clinicaltrials.gov) - Jun 6, 2018
P2, N=80, Recruiting, Sponsor: LIB Therapeutics LLC