Actively Recruiting
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Led by Amryt Pharma · Updated on 2026-01-20
15
Participants Needed
12
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Generalised Lipodystrophy
- Metreleptin treatment naive
You will not qualify if you...
- Weight less than 9 kg at Screening (Visit 1)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Hôpital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
3
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, France
Actively Recruiting
4
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Not Yet Recruiting
5
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany, 89075
Actively Recruiting
6
IRCCS Ospedale Pediatrico Bambino Gesù
Chieti, Italy, 66100
Actively Recruiting
7
Azienda Ospedaliera Universitaria "Federico II"
Naples, Italy, 80131
Actively Recruiting
8
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Italy, 28100
Actively Recruiting
9
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
10
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
11
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, Italy, 00165
Actively Recruiting
12
Ospedale Filippo Del Ponte Varese - ASST Sette Laghi
Varese, Italy, 21100
Actively Recruiting
Research Team
J
Janet Boylan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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