Trials
LAPLACE-TIMI 57
Trial LAPLACE-TIMI 57 (LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition combined with statin therapy- Thrombolysis in Myocardial Infarction) trial. Aim To assess the efficacy, safety, and tolerability of evolocumab in stable patients with hypercholesterolaemia on a statin. Study design Multicentre,…
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MENDEL-2
Trial MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently not Receiving Drug Therapy for Easing Lipid Levels) trial Aim To compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patients with hypercholesterolaemia Study design Randomised controlled, placebo-controlled phase 3…
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MENDEL
Trial MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels) Aim To assess the effects of evolocumab in patients with hypercholesterolaemia in the absence of concurrent lipid-lowering treatment. Study design Phase 2 multicentre, double-blind…
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OSLER-2
Trial OSLER-2 (Open Label Study of Long Term Evaluation Against LDL-C Trial-2) Aim To evaluate the long-term safety, tolerability and efficacy of evolocumab (AMG 145) in subjects with hyperlipidaemia and subjects with mixed dyslipidaemia Study design Multicentre, controlled, open-label extension (OLE) study Evolocumab versus standard…
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OSLER
Trial OSLER (Open label study of long-term evaluation against LDL-C) study Aim To determine long-term efficacy and safety of evolocumab Study design Patients were randomised 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care (SOC) (n=736) or SOC…
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PLEASe
Trial Evolocumab for PCSK9 Lowering in Early Acute Sepsis (The PLEASe Study) ClinicalTrials.gov Identifier: NCT03869073 Aim To evaluate evolocumab in patients with early acute sepsis Study design Randomized, double-blind, placebo-controlled study. Upon enrolling in the study patients will be randomized to treatment with evolocumab 420…
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POOLED ANALYSIS
Trial Pooled analysis of 4 trials Aim To assess the effect of evolocumab on lipoprotein (a) (Lp(a)) Study design Pooled analysis of 4 phase II trials Evolocumab given at 140 mg every 2 weeks and 420 mg every 4 weeks Patient population 1359 patients Primary…
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RUTHERFORD-2
Trial RUTHERFORD-2 (RedUction of LDL-C with PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study-2) Aim To investigate the safety, efficacy and tolerability of PCSK9 inhibition with evolocumab on LDL-C levels in patients with heterozygous familial hypercholesterolaemia (HeFH). Study design Phase 3, 12-week randomised, placebo-controlled, double-blind…
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RUTHERFORD
Trial RUTHERFORD (the Reduction of LDL-C with PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder randomised trial) Aim To evaluate the efficacy and safety of evolocumab in heterozygous familial hypercholesterolaemia patients. Study design Phase 2, multicenter, double-blind, randomised, placebo-controlled, dose-ranging study. Patient population Patients (≥ 18 to ≤…
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TAUSSIG
Trial TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders (Ongoing study) Aim To assess the long term safety and efficacy of evolocumab on LDL-C in subjects with homozygous familial hypercholesterolaemia or PCSK9 mutations. Study design Phase 2/3 multicentre…
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TESLA
Trial TESLA-Pilot (Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities) Aim To evaluate the efficacy and safety of evolocumab in patients with homozygous familial hypercholesterolaemia Study design Open-label, single-arm, multicentre, dose scheduling pilot studySubcutaneous evolocumab, 420 mg every 4 weeks for ≥12 weeks,…
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VESALIUS-CV
Trial VESALIUS-CV (Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke) ClinicalTrials.gov Identifier: NCT03872401 Aim To investigate the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI)…
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YUKAWA
Trial YUKAWA study (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) Aim To evaluate the efficacy and safety of evolocumab in statin-treated Japanese patients at high cardiovascular risk Study design 12-week, phase 2, randomized, multicentre, double-blind, placebo-controlled,…
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ORION-1
ORION-1 Trial A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C Aim Primary: To evaluate the effect of ALN-PCSSC treatment on LDL-C levels at…
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ORION-2
Trial A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (ORION-2) ClinicalTrials.gov Identifier: NCT02963311 Aim To assess the safety, tolerability, and efficacy of inclisiran in participants with homozygous familial hypercholesterolemia (FH) Study Design Open-Label, Single-Arm, Multicenter Pilot Study Patient population 10 patients with homozygous…
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ORION-3
Trial An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol ClinicalTrials.gov Identifier: NCT03060577 Aim To assess the effect of long term dosing of Inclisiran and Evolocumab in patients with high cardiovascular risk and elevated LDL-C Study Design Long-term…
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HPS-4/TIMI 65 ORION-4
Trial HPS-4/TIMI 65 ORION-4: Cardiovascular outcomes study Aim To assess the effect of inclisiran on major cardiovascular events Study design Randomised, double-blind, placebo-controlled. Patients will be randomised to treatment with inclisiran sodium 300 mg or matching placebo for a median of about 5 years. Treatment…
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ORION-5
Trial A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5) ClinicalTrials.gov Identifier: NCT03851705 Aim To evaluate the safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH) Study Design Multicentre Phase III study conducted in two parts; double-blind placebo-controlled…
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ORION-7
Trial A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function ClinicalTrials.gov Identifier: NCT03159416 Aim To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and…
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ORION-8
Trial Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8) ClinicalTrials.gov Identifier: NCT03814187 Aim To evaluate the efficacy, safety, and tolerability of long-term dosing of inclisiran. Study Design Global multicentre, open label, long…
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