NCT04710056

Brief Summary

Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

First QC Date

January 13, 2021

Last Update Submit

March 10, 2026

Conditions

Keywords

Leptin (LEP)Leptin Receptors (LEPR)Biallelic Loss of Function Variants of the LEP Gene

Interventions

To be provided by Regeneron

Also known as: mibavademab

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LipodystrophyLipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Requests for Expanded Access must be initiated by a treating physician. Physicians should contact

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 14, 2021

Last Updated

March 12, 2026

Record last verified: 2026-03