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Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

NCT06502990

TerminatedPhase 3

Sponsor: Amryt Pharma

Conditions: Generalized Lipodystrophy

Interventions: Metreleptin

Countries: Belgium, France, Germany, Italy

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

Eligibility overview

Sex: ALL

Age: — to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Confirmed diagnosis of Generalised Lipodystrophy
* Metreleptin treatment naive

Exclusion Criteria:

* Weight \<9 kg at Screening (Visit 1)
Locations (12)
  • Leuven, Leuven, Belgium
  • Paris, Paris, France
  • Paris, France
  • Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Ulm, Ulm, Germany
  • Chieti, Chieti, Italy
  • Naples, Naples, Italy
  • Novara, Novara, Italy
  • Parma, Parma, Italy
  • Pisa, Pisa, Italy
  • Rome, Rome, Italy
  • Varese, Varese, Italy