Status:
RECRUITING
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Lead Sponsor:
Amryt Pharma
Conditions:
Generalized Lipodystrophy
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE3
Brief 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 dia...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Generalised Lipodystrophy
- Metreleptin treatment naive
Exclusion
- Weight \<9 kg at Screening (Visit 1)
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06502990
Start Date
May 23 2025
End Date
September 30 2026
Last Update
June 22 2025
Active Locations (12)
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1
UZ Leuven
Leuven, Belgium, 3000
2
Hôpital Necker - Enfants Malades
Paris, France, 75015
3
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France
4
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251