drugset / Trial / NCT04026178
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-11-14
- Primary completion
- 2024-10-31
- Completion
- 2024-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metreleptin | Protein / enzyme biologic | 0.06 mg/kg | Subcutaneous |
| Subject | Metreleptin | Protein / enzyme biologic | 2.5 mg | Subcutaneous |
| Subject | Metreleptin | Protein / enzyme biologic | 5 mg | Subcutaneous |