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| ID | Type | Description | Link |
|---|---|---|---|
| APG-20 OLE | Other Identifier | Amryt Pharmaceuticals DAC |
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This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects 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 |
|---|---|---|
| Evaluate the Incidence and Frequency of Treatment-Emergent Adverse Events (Safety and Tolerability) | Incidence and frequency of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), treatment-related TEAEs, adverse events of special interest (AESI), and adverse events leading to study treatment discontinuation/withdrawal from the study | From enrollment to the end of treatment (until the last participant completes 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the long-term efficacy (HbA1c) of daily SC metreleptin treatment in participants with familial partial lipodystrophy (FPLD) | Glycated hemoglobin (HbA1c) in participants with HbA1c ≥7% at the Parent study Baseline, over time during the OLE | From enrollment to the end of treatment (until the last participant completes 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori Hartnett, PhD | Contact | +3905212791 | clinicaltrials_info@chiesi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D052496 | Lipodystrophy, Familial Partial |
| ID | Term |
|---|---|
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008060 | Lipodystrophy |
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| ID | Term |
|---|---|
| C415771 | metreleptin |
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| To evaluate the long-term efficacy (TGs) of daily SC metreleptin treatment in participants with FPLD |
- Fasting triglycerides (TGs) in participants with TG ≥500 mg/dL at the Parent study Baseline, over time during the OLE |
| From enrollment to the end of treatment (until the last participant completes 24 months) |
| To evaluate the long-term efficacy (FBG) of daily SC metreleptin treatment in participants with FPLD |
| From enrollment to the end of treatment (until the last participant completes 24 months) |
| Flourish Research | Recruiting | Boca Raton | Florida | 33434 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| University of Michigan | Recruiting | Ann Arbour | Michigan | 48109 | United States |
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| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| The Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |