Amgen: Hypercholesterolemia trials

The registry lists 25 Hypercholesterolemia studies with Amgen as lead sponsor. 1 are open to participants now and 20 have results posted.

Phase 2 5Phase 3 16Phase 4 2No phase 4(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical AtheromaNot yet recruitingNCT07803679Phase 4
• Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed DyslipidemiaTerminatedNCT03433755Phase 3Results posted
• Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial HypercholesterolemiaCompletedNCT03403374Phase 4Results posted
• Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed DyslipidemiaCompletedNCT02739984Phase 3Results posted
• Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4CompletedNCT02634580Phase 3Results posted
• Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)CompletedNCT02624869Phase 3Results posted
• Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study EnrollmentCompletedNCT02585895Phase 3Results posted
• Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) DisordersCompletedNCT02392559Phase 3Results posted
• Open-label Extension (OLE) Study to Assess Safety and Efficacy of EvolocumabCompletedNCT02304484Phase 3Results posted
• Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular RiskCompletedNCT01953328Phase 3Results posted
• Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/PenCompletedNCT01879319Phase 3Results posted
• Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/PenCompletedNCT01849497Phase 3Results posted
• GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular UltrasoundCompletedNCT01813422Phase 3Results posted
• Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated RiskCompletedNCT01764633Phase 3Results posted
• Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2CompletedNCT01763918Phase 3Results posted
• A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese SubjectsCompletedNCT01652703Phase 2Results posted
• Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL DisordersCompletedNCT01624142Phase 2/3Results posted
• Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor AbnormalitiesCompletedNCT01588496Phase 2/3Results posted
• Durable Effect of PCSK9 Antibody CompARed wiTh placEbo StudyCompletedNCT01516879Phase 3Results posted
• Open Label Study of Long Term Evaluation Against LDL-C TrialCompletedNCT01439880Phase 2Results posted
• Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder StudyCompletedNCT01375751Phase 2Results posted
• Evolocumab Pregnancy Exposure RegistryTerminatedNCT02957604
• Study to Evaluate the Safety of Repatha® in PregnancyTerminatedNCT02906124
• Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in JapanCompletedNCT02808403
• Chart Review of Repatha® in Subjects With HyperlipidaemiaCompletedNCT02770131