Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy

Generalized Lipodystrophy Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Generalized Lipodystrophy
• Lipodystrophy

• NCT number: NCT04026178
• Study type: Interventional
• Source: Aegerion Pharmaceuticals, Inc.
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 14, 2018
• Completion date: April 2025