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

Study Identifier:
APL-20
ClinicalTrials.gov Identifier:
NCT06502990
EudraCT Identifier:
N/A
EU CT ID:
2022-501781-22-00
Study Contact Information:
+3905212791 or [email protected]
Recruiting

Study Details

Medical Condition
  • Generalized Lipodystrophy
Study Drug
  • Drug: Metreleptin
Date
May 2025 - Sep 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - 5 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Confirmed diagnosis of Generalised Lipodystrophy
  • Metreleptin treatment naive
Exclusion Criteria
  • Weight \<9 kg at Screening (Visit 1)
Healthy Volunteers
No

Protocol 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

Study Locations

Location
Status
Location
UZ Leuven
Leuven, Belgium, 3000
Status
Recruiting
Location
Hôpital Necker - Enfants Malades
Paris, France, 75015
Status
Recruiting
Location
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France
Status
Recruiting
Location
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Status
Not yet recruiting
Location
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany, 89075
Status
Recruiting
Location
IRCCS Ospedale Pediatrico Bambino Gesù
Chieti, Italy, 66100
Status
Recruiting
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