Evaluating Metreleptin for Partial Lipodystrophy
Official title: 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
Run by Amryt Pharma · NCT06484868 · Data updated 2026-11-12
This study is testing if daily injections of Metreleptin can help people with partial lipodystrophy manage their symptoms better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Amryt Pharma Industry-sponsored |
| Locations | 12 sites (Lille and 11 other locations) |
| Status | Recruiting |
| Started | February 8, 2024 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT06484868 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a confirmed diagnosis of familial or acquired partial lipodystrophy.
✕Probably not a fit
Patients who have received any investigational medicinal product within the last six months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using Metreleptin for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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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 -
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy Recruiting
Show 6 more locations
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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 -
Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin
Ulm, Germany Not yet recruiting -
Universitá degli Studi "Magna Graecia" di Catanzaro
Catanzaro, Italy Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Blocking growth hormone to help with severe insulin resistance
This study is testing if a medication that blocks growth hormone can help people with severe insulin resistance feel better and improve their metabolism.
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Registry for patients treated with metreleptin for lipodystrophy
This study is collecting information from patients with lipodystrophy who are being treated with metreleptin to see how well it works and what side effects it might cause in real life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.