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

Recruiting now · Phase 4

Conditions studied: Partial Lipodystrophy

In brief

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

Key facts

Study ID

NCT06484868

Run by

Amryt Pharma

People needed

12

Starts

2024-02-08

Expected to finish

2028-02-01

Last updated by the study team

2025-07-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of familial or acquired partial lipodystrophy

You may not qualify if…

• 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.
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez — Lille, France (enrolling)
• Hopital Pitie-Salpetriere — Paris, France (enrolling)
• Hôpital Saint-Antoine — Paris, France (enrolling)
• Centre Hospitalier Lyon-Sud — Pierre-Bénite, France (enrolling)
• Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) — Berlin, Germany (enrolling)
• Azienda Ospedaliero Universitaria Maggiore della Carità di Novara — Novara, Italy (enrolling)
• Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello — Pisa, Italy (enrolling)
• A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia — Udine, Italy (enrolling)
• Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi — Bologna, Italy (enrolling)
• Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin — Ulm, Germany
• Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital — Cambridge, United Kingdom
• Universitá degli Studi "Magna Graecia" di Catanzaro — Catanzaro, Italy

Full record on ClinicalTrials.gov

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