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Trials

A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease

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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EPIC-HIV

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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INTENSITY-HIGH

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

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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Phase 3 study in homozygous FH

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

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

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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ODYSSEY ALTERNATIVE

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

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

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

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

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

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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ODYSSEY DM-Dyslipidemia

ODYSSEY DM-Dyslipidemia

Trial ODYSSEY DM-Dyslipidemia: Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidaemia ClinicalTrials.gov Identifier: NCT02642159 Aim To show the superiority of alirocumab versus usual care in the reduction of non-HDL-C…

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ODYSSEY DM – Insulin

ODYSSEY DM – Insulin

Trial Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM – Insulin) ClinicalTrials.gov Identifier: NCT02585778 Aim To demonstrate the superiority…

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ODYSSEY FH I and II

ODYSSEY FH I and II

Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)Clinical Trials Number: NCT01623115 Study of Alirocumab (REGN727/ SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia)…

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ODYSSEY ESCAPE

ODYSSEY ESCAPE

Trial Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy (ODYSSEY ESCAPE) Clinical Trials Number: NCT02326220 Aim to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with…

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ODYSSEY High FH

ODYSSEY High FH

Trial Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY High FH) Aim To evaluate the effect of alirocumab on LDL cholesterol levels after 24 weeks of treatment in comparison with placebo (on top…

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ODYSSEY HoFH

ODYSSEY HoFH

Alirocumab   Trial Study in Participants With Homozygous Familial Hypercholesterolemia (ODYSSEY HoFH) ClinicalTrials.gov Identifier: NCT03156621 Aim To assess low-density lipoprotein cholesterol (LDL-C) reduction with alirocumab in adult patients with HoFH. Study design Randomised, double-blind, placebo-controlled, parallel-group, phase 3 study. Eligible patients were randomly allocated (2:1)…

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ODYSSEY JAPAN

ODYSSEY JAPAN

Trial ODYSSEY JAPAN Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy Aim To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin…

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