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Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Sponsor: Amryt Pharma
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
Official title: A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2024-02-08
Completion Date
2028-02
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
Metreleptin
Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency
Locations (12)
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
Lille, France
Hopital Pitie-Salpetriere
Paris, France
Hôpital Saint-Antoine
Paris, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, Germany
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy
Universitá degli Studi "Magna Graecia" di Catanzaro
Catanzaro, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
Pisa, Italy
A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia
Udine, Italy
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, United Kingdom