ClinicalTrials.gg
AvailableNCT04710056Updated Oct 27, 2026

Compassionate Use or Expanded Access of Mibavademab

An expanded access record providing REGN4461 in Lipodystrophy, Generalized Lipodystrophy (GLD) and Monogenic Obesity (MOB), sponsored by Regeneron Pharmaceuticals. Available. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Regeneron Pharmaceuticals · Expanded access

Updated Oct 27, 2026Title changedGo to Updates ↓
Study type
Expanded access
Access type
Individual patients · Intermediate-size population · Treatment IND/protocol
Sex
All
01

Study summary

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

Read the detailed description

Expanded Access requests are only being considered in response to Individual Patient and Intermediate-Size Population EAP Investigational New Drug (IND) applications. Availability will depend on location.

02

Conditions studied

  • Lipodystrophy
  • Generalized Lipodystrophy (GLD)
  • Monogenic Obesity (MOB)

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Keywords

  • Leptin (LEP)
  • Leptin Receptors (LEPR)
  • Biallelic Loss of Function Variants of the LEP Gene
03

In context

Lipodystrophy

139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.

Browse Lipodystrophy studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Eligibility criteria

Key Inclusion: N/A

Key Exclusion: N/A

05

Access details

Study type
Expanded access
Access type
Individual patients · Intermediate-size population · Treatment IND/protocol

Available treatment

  • To be provided by Regeneron

    Also known as: mibavademab

06

Where to request access

No study locations are listed for this record.

07

Updates

1 registry update since Sep 25, 2026
Title
Expanded Access to REGN4461 for Patients With Diseases Associated With Deficient Leptin Signaling→Compassionate Use or Expanded Access of Mibavademab
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Title Expanded Access to REGN4461 for Patients With Diseases Associated With Deficient Leptin Signaling→Compassionate Use or Expanded Access of Mibavademab
    + 2 other changes: verification date and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT04710056
Responsible party
Sponsor
First posted
Jan 14, 2021
Last update
Oct 27, 2026

Study contacts

Requests for Expanded Access must be initiated by a treating physician. Physicians should contact
Contact
Managedaccessrequests@regeneron.com
844-734-6643
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

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