Status:
RECRUITING
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Lead Sponsor:
Amryt Pharma
Conditions:
Partial Lipodystrophy
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy
Eligibility Criteria
Inclusion
- Confirmed diagnosis of familial or acquired partial lipodystrophy
Exclusion
- Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.
- Other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06484868
Start Date
February 8 2024
End Date
February 1 2028
Last Update
July 3 2025
Active Locations (12)
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1
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, France
2
Hopital Pitie-Salpetriere
Paris, France
3
Hôpital Saint-Antoine
Paris, France
4
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France