Trials
Trial to evaluate efficacy and safety of lerodalcibep (LIB003) and inclisiran in high risk CVD patients (LIBerate-VI) (NCT05004675)
Study title/design Trial to evaluate efficacy and safety of lerodalcibep (LIB003) and inclisiran in high risk CVD patients (LIBerate-VI) (NCT05004675) Trial NCT05004675/LIB003-012 (Completed: 15 October 2024). Aim To compare LDL-C reductions with lerodalcibep 300 mg and inclisiran 284 mg in patients at very high or…
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Study of efficacy and safety of lerodalcibep (LIB003) in patients with CVD on statins requiring additional LDL-C reduction (LIBerate-CVD) (NCT04797247)
Study title/design Study of efficacy and safety of lerodalcibep (LIB003) in patients with CVD on statins requiring additional LDL-C reduction (LIBerate-CVD) (NCT04797247) Trial NCT04797247/LIB003-005 (Completed) Aim To assess LDL-C reductions at week 52 with monthly (Q4W) dosing of lerodalcibep 300 mg s.c. compared to placebo…
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Study to assess the efficacy and safety of lerodalcibep (LIB003) in patients with HeFH on oral lipid therapy needing further LDL-C reduction (LIBerate-FH) (NCT04797104)
Study title/design Study to assess the efficacy and safety of lerodalcibep (LIB003) in patients with HeFH on oral lipid therapy needing further LDL-C reduction (LIBerate-FH) (NCT04797104) Trial NCT04797104/LIB003-004 (Completed) Aim To assess LDL-C reductions at week 24 and the mean of weeks 22 and 24…
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Study of long term efficacy and safety of lerodalcibep (LIB003) in patients with CVD or high risk for CVD needing further LDL-C Reduction (LIBerate-HR, NCT04806893)
Study title/design Study of long term efficacy and safety of lerodalcibep (LIB003) in patients with CVD or at high risk of CVD needing further LDL-C reduction (LIBerate-HR, NCT04806893) Trial NCT04806893/LIB003-006 (Completed) Aim To assess LDL-C reductions at week 52 with lerodalcibep 300 mg s.c. every…
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Phase 3 study to evaluate the efficacy and safety of lerodalcibep (LIB003) with evolocumab in HoFH (NCT04034485)
Study title/design Phase 3 study to evaluate the efficacy and safety of lerodalcibep (LIB003) with evolocumab in HoFH (NCT04034485) Trial CT04034485/LIB003-003 (Completed) Aim To compare the safety, tolerability and LDL-C response after 24 weeks of LIB003 300 mg s.c every 4 weeks with evolocumab 420…
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Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513)
Study title/design Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513) Trial NCT04790513/LIB003-011 (Completed). Aim To compare LDL-C reductions at week 12 of monthly lerodalcibep 300 mg s.c., evolocumab 420 mg s.c., and alirocumab…
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Open label extension to evaluate the longer term efficacy of lerodalcibep (LIB003) (NCT03847974)
Study title/design Open label extension to evaluate the longer term efficacy of lerodalcibep (LIB003) (NCT03847974) Trial NCT03847974 (Completed) Aim To assess the longer term safety, tolerability and LDL-C lowering efficacy of LIB003 administered every 4 weeks, after 52 weeks. Study Design Open label Phase 2b…
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Study to evaluate efficacy and safety of LIB003 in patients on lipid-lowering therapy needing additional LDL-C reduction (NCT03549260)
Study title/design Study to evaluate efficacy and safety of LIB003 in patients on lipid-lowering therapy needing additional LDL-C reduction (NCT03549260) Trial NCT03549260/LIB003-002 (Completed) Aim To assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in participants on stable statin and/or…
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A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease (Heart-1)
Study title/design: A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease (Heart-1) Trial A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease ClinicalTrials.gov Identifier: NCT05398029 (Active, not recruiting) Recruitment initiated July 2022 Estimated primary completion: December 2024 Estimated study…
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Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH)
Trial Alirocumab: 1-year data in heterozygous familial hypercholesterolaemia (HeFH) Aim To report safety and efficacy data after 52 weeks of a 4- year extension to an earlier 12-week trial (R727-CL-1003) of alirocumab or placebo in patients with HeFH on statin ± ezetimibe Study design Phase…
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Alirocumab combination with ezetimibe or fenofibrate
Trial Alirocumab ± ezetimibe or fenofibrate in healthy subjects: PK and PD data Aim To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe (EZE) or fenofibrate (FEN), based on LDL-C Study design Open-label, partial-blind, 3 parallel group pharmacodynamics study…
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Alirocumab effects on lipoprotein particles
Trial Effects of alirocumab on lipoprotein particle concentrations Aim To determine the effects of alirocumab on LDL particle (LDL-P) and other lipid particle concentrations to assess cardiovascular risk Study design Sub-study of phase 2, randomised, double blind efficacy study Patient population Patients with LDL-C ≥100mg/dL…
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Alirocumab single dose study
Trial Alirocumab single dose study: bioavailability, pharmacodynamics, and safety Aim To assess the bioavailability of a single dose of alirocumab after injection in the abdomen, upper arm, and thigh Study design Single-centre, open-label, randomized Phase 1 study Patient population Healthy subjects (aged 18-45 years) in…
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EPIC-HIV
Trial Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) ClinicalTrials.gov Identifier: NCT03207945 Aim To determine whether PCSK9 inhibition can improve arterial inflammation as assessed by FDG-PET/CT, and endothelial function as assessed by flow mediated vasodilation. The investigators will correlate changes…
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EPIC-STEMI
Trial Effects of Acute, Rapid Lowering of LDL Cholesterol With Alirocumab in Patients With STEMI Undergoing Primary PCI (EPIC STEMI) ClinicalTrials.gov Identifier: NCT03718286 Aim To investigate the effect of acute, rapid lowering of low-density lipoprotein cholesterol (LDL-C) with alirocumab added to high dose statin therapy…
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Heterozygous FH
Trial Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia Aim To assess the efficacy and safety of various doses and dosing intervals of alirocumab, added to statins, in lowering LDL-C in patients with heterozygous familial hypercholesterolaemia (HeFH). Study design Multicentre,…
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Hypercholesterolaemia on statin
Trial McKenney et al., 2012 Aim To evaluate the LDL-C lowering efficacy of alirocumab in patients with elevated LDL-C levels on stable atorvastatin therapy. Study design Phase 2 multicentre, randomised, double-blind placebo-controlled, parallel group study. Patient population 183 patients with LDL-C levels ³2.59 mmol/L (100…
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INTENSITY-HIGH
Trial INTENSITY-HIGH: Investigating the Lowest Threshold of Vascular Benefits from LDL Cholesterol Lowering with a PCSK9 mAb Inhibitor (Alirocumab) in Patients with Stable Cardiovascular Disease. ClinicalTrials.gov Identifier: NCT03355027 Aim To investigate if there are any limits to LDL reduction in relation to benefiting vascular health,…
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MEMOGAL
Trial Study to Evaluate Changes in Cognitive Function in Patients Treated With PCSK9 Inhibitors (MEMOGAL) (NCT04319081) Aim To evaluate changes in the cognitive function in naive patients treated with PCSK9 inhibitors (alirocumab and evolocumab) using the Montreal Cognitive Assesment questionnaire (MOCA). Study design Multicentre, observational,…
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ODYSSEY ALTERNATIVE
Trial Study of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (Odyssey Alternative) Aim To evaluate the efficacy and safety of alirocumab in patients with primary hypercholesterolaemia who are intolerant to…
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