drugset / Trial / NCT06548100

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

NCT06548100

Phase 3 Active not recruiting 9 enrolled Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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)

Timeline

Start
2024-12-16
Primary completion
2026-07-14
Completion
2026-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Mibavademab Monoclonal antibody Intravenous