Studies
| Study First Submitted Date | 2021-01-13 |
| Study First Posted Date | 2021-01-14 |
| Last Update Posted Date | 2022-03-24 |
| Verification Month Year | March 2022 |
| Verification Date | 2022-03-31 |
| Last Update Posted Date | 2022-03-24 |
Detailed Descriptions
| Sequence: | 20588198 |
| Description | Expanded Access requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location. |
Conditions
| Sequence: | 51827645 | Sequence: | 51827643 | Sequence: | 51827644 |
| Name | Monogenic Obesity Due to LEP or LEPR Loss of Function | Name | Generalized Lipodystrophy | Name | Partial Lipodystrophy |
| Downcase Name | monogenic obesity due to lep or lepr loss of function | Downcase Name | generalized lipodystrophy | Downcase Name | partial lipodystrophy |
Id Information
| Sequence: | 39884401 |
| Id Source | org_study_id |
| Id Value | R4461-LEPR |
Interventions
| Sequence: | 52148739 |
| Intervention Type | Drug |
| Name | REGN4461 |
Keywords
| Sequence: | 79307532 | Sequence: | 79307533 |
| Name | Leptin (LEP) | Name | Leptin Receptors (LEPR) |
| Downcase Name | leptin (lep) | Downcase Name | leptin receptors (lepr) |
Browse Conditions
| Sequence: | 192100978 | Sequence: | 192100968 | Sequence: | 192100969 | Sequence: | 192100970 | Sequence: | 192100971 | Sequence: | 192100972 | Sequence: | 192100973 | Sequence: | 192100974 | Sequence: | 192100975 | Sequence: | 192100976 | Sequence: | 192100977 | Sequence: | 192100979 | Sequence: | 192100980 | Sequence: | 192100981 |
| Mesh Term | Metabolic Diseases | Mesh Term | Lipodystrophy, Congenital Generalized | Mesh Term | Lipodystrophy | Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight | Mesh Term | Skin Diseases, Metabolic | Mesh Term | Skin Diseases | Mesh Term | Lipid Metabolism Disorders | Mesh Term | Lipid Metabolism, Inborn Errors | Mesh Term | Metabolism, Inborn Errors | Mesh Term | Genetic Diseases, Inborn |
| Downcase Mesh Term | metabolic diseases | Downcase Mesh Term | lipodystrophy, congenital generalized | Downcase Mesh Term | lipodystrophy | Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight | Downcase Mesh Term | skin diseases, metabolic | Downcase Mesh Term | skin diseases | Downcase Mesh Term | lipid metabolism disorders | Downcase Mesh Term | lipid metabolism, inborn errors | Downcase Mesh Term | metabolism, inborn errors | Downcase Mesh Term | genetic diseases, inborn |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 47999916 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Regeneron Pharmaceuticals |
Central Contacts
| Sequence: | 11939111 |
| Contact Type | primary |
| Name | Requests for compassionate use must be initiated by a treating physician. Physicians should contact |
| Phone | 844-734-6643 |
| CompassionateUse_Requests@regeneron.com | |
| Role | Contact |
Eligibilities
| Sequence: | 30563818 |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254254456 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
Responsible Parties
| Sequence: | 28690737 |
| Responsible Party Type | Sponsor |