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ACTIVE NOT RECRUITING
NCT06548100
PHASE3

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

Official title: A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2024-12-16

Completion Date

2026-11-03

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

mibavademab

Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection

Locations (2)

National Institutes of Health

Bethesda, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States