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Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Sponsor: Amryt Pharma
Summary
This is an open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia
Official title: Open-label, Phase 3b Study to Evaluate Effectiveness, Safety and Pharmacokinetic Parameters of Metreleptin in Patients Under 6 Years of Age With Generalised Lipodystrophy and Associated Diabetes Mellitus and/or Hypertriglyceridaemia
Key Details
Gender
All
Age Range
Any - 5 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-05-23
Completion Date
2026-09-30
Last Updated
2026-01-20
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)
UZ Leuven
Leuven, Belgium
Hôpital Necker - Enfants Malades
Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany
IRCCS Ospedale Pediatrico Bambino Gesù
Chieti, Italy
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Italy
Ospedale Filippo Del Ponte Varese - ASST Sette Laghi
Varese, Italy