Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
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
Amryt Pharma
12 participants
Feb 8, 2024
INTERVENTIONAL
Conditions
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 Criteria1
- Confirmed diagnosis of familial or acquired partial lipodystrophy
Exclusion Criteria1
- 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.
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Interventions
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
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06484868