Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
NCT ID: NCT06502990
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
15 participants
INTERVENTIONAL
2025-05-23
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metreleptin
Metreleptin \[Recombinant-methionyl human Leptin; rmetHuLeptin\] for daily injection is a sterile, white, solid lyophilised cake
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Metreleptin treatment naive
Exclusion Criteria
5 Years
ALL
No
Sponsors
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Amryt Pharma
INDUSTRY
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Hôpital Necker - Enfants Malades
Paris, , France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
Paris, , France
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, , Germany
IRCCS Ospedale Pediatrico Bambino Gesù
Chieti, , Italy
Azienda Ospedaliera Universitaria "Federico II"
Naples, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, , Italy
Ospedale Filippo Del Ponte Varese - ASST Sette Laghi
Varese, , Italy
Countries
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Central Contacts
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Facility Contacts
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Kristina Casteels
Role: primary
Jacques Beltrand
Role: primary
Elise Bismuth
Role: primary
Konstantinos Tsiakas
Role: primary
Martin Wabitsch
Role: primary
Stefano Tumini
Role: primary
Enza Mozzillo
Role: primary
Flavia Prodam
Role: primary
Maria Street
Role: primary
Giovanni Ceccarini
Role: primary
Marco Cappa
Role: primary
Gianluca Musolino
Role: primary
Other Identifiers
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2022-501781-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
APL-20
Identifier Type: -
Identifier Source: org_study_id
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