clinical trial · NCT04026178
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
Aegerion Pharmaceuticals, Inc.·phase4·completed·n = 11
Generalized LipodystrophyMetreleptin
brief summary
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.
started
Nov 14, 2018
primary completion
Oct 31, 2024
completion
Oct 31, 2024
last updated
Nov 26, 2025
official title
A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol