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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502950-14-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metreleptin | Experimental | Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metreleptin | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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%. | To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL | 12 months |
| 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) | To evaluate the efficacy (TG) of metreleptin treatment in patients with PL | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with decrease of at least 0.5% in HbA1c at Month 24 compared to Baseline or HbA1c <6.5 % at Month 24, in patients with baseline HbA1c ≥6.5%. | To evaluate the long-term efficacy of metreleptin treatment in patients with PL | 24 months |
| Number of patients with decrease of at least 30% in TG levels at Month 24 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Boylan | Contact | +3905212791 | clinicaltrials_info@chiesi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Recruiting | Lille | France |
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| ID | Term |
|---|---|
| C562448 | Lipodystrophy, Partial, Acquired |
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| ID | Term |
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| C415771 | metreleptin |
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To evaluate the long-term efficacy of metreleptin treatment in patients with PL |
| 24 months |
| Change from baseline in liver volume at Month 12 and Month 24 | To assess changes in liver volume. | 12 months and 24 months |
| Incidence of, Treatment emergent adverse events (TEAEs), Deaths and other serious adverse events (SAEs), Treatment related adverse events (AEs), AEs of special interest (AESIs) and AEs leading to study drug discontinuation | To evaluate the safety of metreleptin treatment in patients with PL | 24 months |
| Hopital Pitie-Salpetriere | Recruiting | Paris | France |
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| Hôpital Saint-Antoine | Recruiting | Paris | France |
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| Centre Hospitalier Lyon-Sud | Recruiting | Pierre-Bénite | France |
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| Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) | Recruiting | Berlin | Germany |
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| Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin | Not yet recruiting | Ulm | Germany |
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| Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi | Recruiting | Bologna | Italy |
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| Universitá degli Studi "Magna Graecia" di Catanzaro | Not yet recruiting | Catanzaro | Italy |
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| Azienda Ospedaliero Universitaria Maggiore della Carità di Novara | Recruiting | Novara | Italy |
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| Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello | Recruiting | Pisa | Italy |
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| A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia | Recruiting | Udine | Italy |
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| Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital | Not yet recruiting | Cambridge | United Kingdom |
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