- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06500598
Compassionate Use of Evinacumab
October 24, 2025 updated by: Regeneron Pharmaceuticals
Provide compassionate use of evinacumab
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Detailed Description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
Availability will depend on location.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 8, 2024
First Submitted That Met QC Criteria
July 8, 2024
First Posted (Actual)
July 15, 2024
Study Record Updates
Last Update Posted (Estimated)
October 28, 2025
Last Update Submitted That Met QC Criteria
October 24, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism Disorders
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Hypertriglyceridemia
- Hyperlipoproteinemia Type III
- evinacumab
Other Study ID Numbers
- R1500-Evinacumab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Homozygous Familial Hypercholesterolemia (HoFH)
-
University of Wisconsin, MadisonRecruitingFamilial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia (HoFH) | Heterozygous Familial Hypercholesterolemia (HeFH)United States
-
AmgenCompletedHomozygous Familial Hypercholesterolemia HoFHIndia
-
REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
-
Eddingpharm (Zhuhai) Co., Ltd.Recruiting
-
Visirna Therapeutics HK LimitedActive, not recruitingHomozygous Familial Hypercholesterolemia (HoFH)China
-
Amryt PharmaCompletedHomozygous Familial Hypercholesterolaemia (HoFH)Germany, Israel, Italy, Saudi Arabia, Spain, Tunisia
-
CRISPR Therapeutics AGRecruitingDyslipidemias | Hypercholesterolaemia | Hypertriglyceridemia | Lipid Disorder | Metabolic Disease | Cardiovascular | Homozygous Familial Hypercholesterolemia (HoFH) | Severe Hypertriglyceridemia (sHTG) | Mixed Hyperlipemia | Heterozygous Familial Hypercholesterolemia (HeFH)United States, Australia, New Zealand, United Kingdom
-
HDL TherapeuticsMedStar Heart and Vascular InstituteUnknownHomozygous Familial Hypercholesterolemia | HoFHUnited States
-
AstraZenecaCompletedHomozygous Familial Hypercholesterolemia (HoFH)Malaysia, Canada, Israel, Netherlands, Taiwan, Belgium, Denmark
-
AstraZenecaCompletedHomozygous Familial Hypercholesterolemia (HoFH)Malaysia, Canada, Taiwan, Belgium, Denmark, Israel
Clinical Trials on Evinacumab
-
Regeneron PharmaceuticalsRecruitingDiabetic Kidney Disease (DKD)United States
-
Regeneron PharmaceuticalsCompletedSevere Hypertriglyceridemia (sHTG)United States, Canada, Italy, United Kingdom
-
Regeneron PharmaceuticalsCompletedHomozygous Familial HypercholesterolemiaUnited States, Netherlands, Australia, Austria, Canada, France, Greece, Italy, Japan, South Africa, Ukraine
-
Regeneron PharmaceuticalsCompletedHealthy VolunteersUnited States
-
Regeneron PharmaceuticalsCompletedHomozygous Familial HypercholesterolemiaUnited States, Australia, Austria, Netherlands, Taiwan, Ukraine
-
Regeneron PharmaceuticalsTerminatedHypertriglyceridemiaUnited States, Germany, Netherlands, Canada
-
Regeneron PharmaceuticalsCompletedHomozygous Familial HypercholesterolemiaUnited States, Netherlands, South Africa, Australia, Austria, Canada, Czechia, France, Greece, Italy, Japan, Ukraine
-
Daniel GaudetUltragenyx Pharmaceutical IncCompletedSafety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaCanada
-
Regeneron PharmaceuticalsCompletedHypercholesterolemiaUnited States, Spain, Australia, Netherlands, Japan, Jordan, Denmark, Israel, Sweden, South Africa, Canada, Austria, Czechia, France, Italy, New Zealand, Norway, Poland, Russian Federation, United Kingdom