- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710056
Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling
October 19, 2023 updated by: Regeneron Pharmaceuticals
Provide Expanded Access to REGN4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling
Study Overview
Status
Available
Conditions
Intervention / Treatment
Detailed Description
Expanded Access 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.
Study Contact
- Name: Requests for compassionate use must be initiated by a treating physician. Physicians should contact
- Phone Number: 844-734-6643
- Email: CompassionateUse_Requests@regeneron.com
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
January 13, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 14, 2021
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R4461-LEPR
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.
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