Evaluating Metreleptin for 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
PHASE4 · Amryt Pharma · NCT06484868
This study is testing if daily injections of Metreleptin can help people with partial lipodystrophy manage their symptoms better.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Amryt Pharma (industry) |
| Locations | 12 sites (Lille and 11 other locations) |
| Trial ID | NCT06484868 on ClinicalTrials.gov |
What this trial studies
This open-label, Phase IV study assesses the efficacy, safety, and immunogenicity of daily subcutaneous Metreleptin treatment in patients diagnosed with partial lipodystrophy. Participants will receive Metreleptin and be monitored for their response to the treatment. The study aims to gather data on how well this medication works in managing the condition and its associated symptoms. It is designed for individuals with either familial or acquired forms of partial lipodystrophy.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of familial or acquired partial lipodystrophy.
Not a fit: Patients who have received any investigational medicinal product within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from partial lipodystrophy.
How similar studies have performed: Previous studies have shown promise in using Metreleptin for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of familial or acquired partial lipodystrophy Exclusion Criteria: * 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 this trial is running
Lille and 11 other locations
- Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez — Lille, France (RECRUITING)
- Hopital Pitie-Salpetriere — Paris, France (RECRUITING)
- Hôpital Saint-Antoine — Paris, France (RECRUITING)
- Centre Hospitalier Lyon-Sud — Pierre-Bénite, France (RECRUITING)
- Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) — Berlin, Germany (RECRUITING)
- Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin — Ulm, Germany (NOT_YET_RECRUITING)
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi — Bologna, Italy (RECRUITING)
- Universitá degli Studi "Magna Graecia" di Catanzaro — Catanzaro, Italy (NOT_YET_RECRUITING)
- Azienda Ospedaliero Universitaria Maggiore della Carità di Novara — Novara, Italy (RECRUITING)
- Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello — Pisa, Italy (RECRUITING)
- A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia — Udine, Italy (RECRUITING)
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital — Cambridge, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Janet Boylan
- Email: clinicaltrials_info@chiesi.com
- Phone: +3905212791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Partial Lipodystrophy, Metreleptin