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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
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
Conditions
Interventions
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