Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
1
Start Date
2025-05-23
Completion Date
2026-02-11
Last Updated
2026-07-22
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, Leuven, Belgium
Hôpital Necker - Enfants Malades
Paris, Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Ulm, Germany
IRCCS Ospedale Pediatrico Bambino Gesù
Chieti, Chieti, Italy
Azienda Ospedaliera Universitaria "Federico II"
Naples, Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Novara, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Parma, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Rome, Italy
Ospedale Filippo Del Ponte Varese - ASST Sette Laghi
Varese, Varese, Italy