Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with PL
Partial LipodystrophyThis is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
12 and up
Critères de participation
Inclusion Criteria:
* Diagnosis of Familial Partial Lipodystrophy (FPLD)
* Subjects with poor metabolic control defined as:
HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3)
* Patients should be receiving optimized stable therapy
Exclusion Criteria:
* Previous treatment with metreleptin
* Leptin levels \>20.0 ng/mL
* Acquired or radiation induced partial lipodystrophy (APL)
Other protocol defined inclusion/exclusion criteria apply
Lieu de l'étude
Nova Scotia Health
Nova Scotia HealthHalifax, Nova Scotia
Canada
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Faculty of Medicine, Universite Laval
Faculty of Medicine, Universite LavalQuébec, Quebec
Canada
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Stanley Weisnagel
Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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Daniel Gaudet
Hamilton General Hospital- McMaster University
Hamilton General Hospital- McMaster UniversityHamilton, Ontario
Canada
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London Health Science Centre
London Health Science CentreLondon, Ontario
Canada
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- Étude parrainée par
- Amryt Pharma
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05164341