Repatha™

Generic Name: evolocumab
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20080397Hypercholesterolemia1

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Healthy Subjects

20080398HYPERCHOLESTEROLEMIA1b

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects with Hyperlipidemia on Stable Doses of a Statin

20090158HYPERCHOLESTEROLEMIA2

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effect of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia.

20090159HYPERCHOLESTEROLEMIA2

A Phase 2, Randomized, Active-Control, Dose-Ranging Study to Evaluate the LDL-C Lowering Properties of AMG 145, Compared to Ezetimibe, When Used Alone or With Low-Dose Statin, in Statin-Intolerant Subjects with Dyslipidemia.

20101154HYPERCHOLESTEROLEMIA2

A Randomized, Multicenter, Blinded, Study to Evaluate the Safety and Efficacy of Subcutaneous AMG 145 compared with Ezetimibe and Placebo in Low Cardiovascular Risk Subjects with Dyslipidemia

20101155HYPERCHOLESTEROLEMIA2

A Phase 2, Randomized, Double-Blind, Placebo and Active Controlled, Dose-Ranging, Multiple-Dose, Parallel-Group Study to Evaluate The LDL-C Lowering Properties of AMG 145, Compared to Placebo and Ezetimibe When Used as Add-on Therapy in Dyslipidemic

20110109HYPERCHOLESTEROLEMIA3

A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects

20110114HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo and Ezetimibe controlled, Multicenter Study to Evaluate Safety and Efficacy of AMG 145 in Subjects With a 10 Year Framingham Risk Score of 10% or Less and Currently Not Receiving Prescription Lipid-lowering Therapy

20110115HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

20110116HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared with Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

20110117HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia

20110121Hyperlipidemia1

A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Healthy Japanese Subjects

20110168Hypercholesterolemia1

An Open Label Randomized Parallel Study in Healthy Volunteers to Compare the Pharmacokinetics of AMG 145 when Delivered Subcutaneously via a 3.5 mL Personal Injector versus 3 Prefilled Autoinjector/Pens

20110231HYPERCHOLESTEROLEMIA2

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia

20110233HYPERCHOLESTEROLEMIA2

A Two Part, Phase 2/3 Study to Assess the Safety and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

20110234Not Applicable0A Randomized, Crossover Study to Evaluate Tolerability of Various SC Infusion Rates of a 3.5 mL Viscous Placebo Buffer in Healthy Subjects
20120101Not Applicable0A Randomized, Crossover Study to Evaluate Tolerability of Various Placebo Formulations With Different Viscosities Administered Subcutaneously via Bolus Injection in Healthy Subjects
20120122HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Japanese Subjects With Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

20120133Hypercholesterolemia1An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of AMG 145 When Delivered Subcutaneously via a Prefilled Syringe Versus a Prefilled Autoinjector/pen
20120135Not Applicable0An Open-label, Non-randomized Study in Healthy Volunteers to Assess Drug Delivery Performance of the 3.5 mL Personal Injector Using Placebo Buffer
20120136Hypercholesterolemia1An Open-label, Crossover, PK/PD Study of AMG 145 to Determine the Intrasubject Variability in Healthy Subjects
20120341Hypercholesterolemia1Open-label, Parallel-group Study Evaluating the Pharmacokinetics of AMG 145 in Hepatic-impaired and Healthy Subjects
20120348HYPERCHOLESTEROLEMIA3

A multi-center, randomized study in patients with primary hypercholesterolemia and mixed dyslipidemia to assess users' ability to administer a full dose of AMG 145 in home-use using either a pre-filled syringe or an autoinjector device AMG 145

20120356HYPERCHOLESTEROLEMIA3

A multi-center, randomized study in patients with primary hypercholesterolemia and mixed dyslipidemia to assess patients' ability to self administer a full dose of AMG 145 in a non-clinic setting

20140213HYPERCHOLESTEROLEMIA1a

Phase I, Open-label, Single-dose Study of Evolocumab (AMG 145) Administered Subcutaneously to Subjects with Hyperlipidemia on Stable Doses of a Statin with Normal Renal Function or Stage 4 Renal Impairment or Stage 5 Renal Impairment Receiving Hemodialysis