Trials
A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
Trial A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease ClinicalTrials.gov Identifier: NCT05398029 Aim To evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolaemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolaemia. Study design Open-label, Phase 1b, single-ascending dose…
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Phase 3 study in homozygous FH
Trial Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH ClinicalTrials.gov Identifier: NCT04034485 Aim To compare the safety, tolerability and low-density lipoprotein cholesterol (LDL-C) response after 24 weeks of 4-weekly subcutaneous (SC) dosing of LIB003 300 mg with 4-weekly…
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Open-label extension study
Trial Open-Label Extension to Evaluate the Longer-Term Efficacy and Safety of LIB003 ClinicalTrials.gov Identifier: NCT03847974 Aim To assess the longer-term safety, tolerability, and low-density lipoprotein cholesterol (LDL-C) lowering efficacy of LIB003 with subcutaneous (SC) dosing every 4 weeks Study Design Open-label; all patients were allocated…
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Phase 2 dose-ranging study
Trial Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction ClinicalTrials.gov Identifier: NCT03549260 Aim To assess the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin…
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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) ClinicalTrials.gov Identifier: 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…
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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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ODYSSEY APPRISE
Trial ODYSSEY APPRISE: Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies ClinicalTrials.gov Identifier: NCT02476006 Aim To assess efficacy and overall safety and tolerability of alirocumab in patients with severe hypercholesterolemia at risk…
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ODYSSEY CHOICE II
Trial Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) Aim To evaluate the efficacy and safety or alirocumab as add-on to non-statin lipid modifying background therapy (ezetimibe or fenofibrate) or as monotherapy in comparison…
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ODYSSEY CHOICE I
Trial Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1) Aim To determine if alirocumab is effective and safe compared with placebo, if used alone or added…
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ODYSSEY COMBO II
Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II) Aim To compare the efficacy [low-density lipoprotein cholesterol (LDL-C) lowering] and safety of alirocumab with ezetimibe, as add-on therapy to maximally tolerated…
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ODYSSEY COMBO I
Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY Combo I) Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL‑C) by alirocumab as add-on therapy to stable maximally tolerated daily…
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