Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Condition(s) studied
Investigational drug(s) / intervention(s)
Mibavademab: Administered as per the protocol
Placebo: Administered as per the protocol
Study 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
Primary outcome measure(s)
- Change in Hemoglobin A1c (HbA1c) — Through 36 weeks of exposure to mibavademab
Part A - Percent change in fasting Triglycerides (TG) — Through 36 weeks of exposure to mibavademab
Part A - Occurrence of Treatment Emergent Adverse Events (TEAEs) — Up to 15 months
Part B - Severity of TEAEs — Up to 15 months
Part B - Concentrations of total mibavademab in serum — Up to 15 months
Part B
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| Walter Cantidio University Hospital, Federal University of Ceara - Ebserh | Fortaleza | Ceará | Recruiting |
| Centro de Pesquisas Clinicas de Natal (Cepclin) | Natal | Rio Grande do Norte | Recruiting |
| UPCO - HCPA - Universidade Federal do Rio Grande do Sul - UFRGS | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital Das Clinicas - School of Medicine Ribeirao Preto, University of Sao Paulo | Ribeirão Preto | São Paulo | Recruiting |
| Instituto Estadual de Diabetes e Endcrinologia | Rio de Janeiro | Brazil | Recruiting |
| Hopital Universitaire Robert-Debre | Paris | France | Recruiting |
| Assistance Publique-Hopitaux de Paris (AP-HP) | Paris | France | Recruiting |
More Regeneron Pharmaceuticals trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07220785 on ClinicalTrials.gov ↗ ← All trials in France