Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Start Date
3/13/2026
Completion Date
9/8/2028
Summary
This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times. This is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in pediatric participants. The study is researching several other questions, including: * How mibavademab affects the amount of sugar in the blood * How mibavademab affects the amount of fat (triglycerides) in the blood * How mibavademab affects the amount of fat that has built up in the liver * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Eligibility Criteria
Age Range: 2 years to No maximum
Interventions
Mibavademab
Placebo
Conditions
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Walter Cantidio University Hospital, Federal University of Ceara - Ebserh
Fortaleza, Ceará 60430-270
Brazil
Centro de Pesquisas Clinicas de Natal (Cepclin)
Natal, Rio Grande do Norte 59025-050
Brazil
Hospital Das Clinicas - School of Medicine Ribeirao Preto, University of Sao Paulo
Ribeirão Preto, São Paulo 14040-906
Brazil
Hopital Universitaire Robert-Debre
Paris, 75019
France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571
France