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

Last updated: July 2, 2025
Sponsor: Amryt Pharma
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Metreleptin

Clinical Study ID

NCT06484868
APL-22
2022-502950-14-00
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion

Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Metreleptin
Phase: 4
Study Start date:
February 08, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

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

    Lille,
    France

    Active - Recruiting

  • Hopital Pitie-Salpetriere

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint-Antoine

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite,
    France

    Active - Recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin,
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin

    Ulm,
    Germany

    Site Not Available

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

    Bologna,
    Italy

    Active - Recruiting

  • Universitá degli Studi "Magna Graecia" di Catanzaro

    Catanzaro,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

    Novara,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

    Pisa,
    Italy

    Active - Recruiting

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

    Udine,
    Italy

    Active - Recruiting

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge,
    United Kingdom

    Site Not Available

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