NCT04026178

Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy

A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Aegerion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Lipodystrophy

Interventions

Type	Name	Description
DRUG	Metreleptin	Subjects will receive prescribed dosage of metreleptin as indicated in the USPI

Timeline

• Start date: 2018-11-14
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2019-07-19
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study