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NCT06548100 · ClinicalTrials.gov registry record · Phase 3

A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)

A Phase 3 study of Generalized Lipodystrophy, sponsored by Regeneron Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
9
Enrollment target
2
Study locations

NCT06548100: Active Phase 3 study of Generalized Lipodystrophy, sponsored by Regeneron Pharmaceuticals.

NCT06548100 is a Phase 3 study of Generalized Lipodystrophy that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06548100, a Phase 3 study of Generalized Lipodystrophy, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
9 participants
Enrollment target
2
Study locations

Study Summary

This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months. The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin. The study is looking at several other research questions, including: * What side effects may happen from taking mibavademab * How much mibavademab is in the blood at different times * Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)

Conditions Studied

Interventions

  • DRUG mibavademab

Study Locations (2)

Maryland

  • National Institutes of Health - Bethesda

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2024-12-16
Est. Completion 2026-11-03
Phase Phase 3
Regeneron Pharmaceuticals

280 total trials

What the registry record for NCT06548100 still lists

NCT06548100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Generalized Lipodystrophy appearing as the primary indexed condition, and to 1 intervention - of which mibavademab is the first listed.

NCT06548100 reports a single indexed study location in Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT06548100 about?

NCT06548100 is a clinical study titled "A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)". This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months. The aim of the study is to see how safe and tolerable mibavademab is when switc...

What is the current status of trial NCT06548100?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2024-12-16. Estimated completion is 2026-11-03.

What conditions does trial NCT06548100 study?

This clinical trial studies the following conditions: Generalized Lipodystrophy.

What interventions are being tested in trial NCT06548100?

The interventions under investigation include: mibavademab (DRUG).

Who is sponsoring clinical trial NCT06548100?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06548100 being conducted?

This trial has 2 study locations across Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06548100's enrollment target sits among peer trials

9 1992nd of 2000 higher than 8 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06548100, the US trial registry maintained by the National Library of Medicine. NCT06548100 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.