Clinical Trials Logo

Clinical Trial Summary

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03399786
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date January 18, 2018
Completion date March 17, 2020

See also
  Status Clinical Trial Phase
Completed NCT04031742 - A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia Phase 2/Phase 3
Not yet recruiting NCT06009393 - Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia Phase 2
Completed NCT03156621 - Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 3
Recruiting NCT06125847 - NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia Early Phase 1
Completed NCT01878604 - Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia N/A
Completed NCT01412034 - Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects Phase 2
Withdrawn NCT02765841 - Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy Phase 3
Completed NCT03933293 - A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH Phase 2
Completed NCT00704535 - Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Recruiting NCT02135705 - LOWER: Lomitapide Observational Worldwide Evaluation Registry
Completed NCT03409744 - Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT04233918 - Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia Phase 3
Withdrawn NCT02399852 - Effects of Lomitapide on Carotid and Aortic Atherosclerosis N/A
Terminated NCT01841684 - Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) Phase 3
Recruiting NCT01109368 - The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
Completed NCT01556906 - Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor Phase 2
Active, not recruiting NCT03135184 - HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia N/A
Recruiting NCT04815005 - HoFH, the International Clinical Collaborators Registry
Completed NCT03851705 - A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 3
Completed NCT02265952 - Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 2