Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Recruiting
Phase 3
Interventional Study
Generalized Lipodystrophy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 28 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
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 pe…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines
For Part A only:
1. Participants ≥2 years of age at screening
2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screenin…
Contacts