RecruitingPhase 4NCT06484868

Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy


Sponsor

Amryt Pharma

Enrollment

12 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy


Eligibility

Min Age: 12 Years

Inclusion Criteria1

  • Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion Criteria1

  • Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.

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Interventions

DRUGMetreleptin

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


Locations(12)

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

Lille, France

Hopital Pitie-Salpetriere

Paris, France

Hôpital Saint-Antoine

Paris, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, Germany

Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin

Ulm, Germany

Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

Bologna, Italy

Universitá degli Studi "Magna Graecia" di Catanzaro

Catanzaro, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

Pisa, Italy

A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

Udine, Italy

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, United Kingdom

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NCT06484868


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