Clinical Trials in France / NCT06484868
Recruiting
Phase 4
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
NCT06484868 · tracked via the Priya Life Science France tracker
Condition(s) studied
Partial Lipodystrophy
Investigational drug(s) / intervention(s)
Metreleptin: 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
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
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
Primary outcome measure(s)
- Number of patients with decrease of at least 0.5% in glycated haemoglobin (HbA1c) at Month 12 compared to Baseline or HbA1c <6.5 % at Month 12, in patients with baseline HbA1c ≥6.5%. — 12 months
To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL - Number of patients with decrease of at least 30% in triglycerides (TG) at Month 12 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L) — 12 months
To evaluate the efficacy (TG) of metreleptin treatment in patients with PL
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06484868 on ClinicalTrials.gov ↗ ← All trials in France