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Mibavademab in Generalized Lipodystrophy Switching From Metreleptin
NCT06548100Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2024
- Primary completion
- Jul 2026
- Countries
- 1
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Monoclonal Antibodies
- Drugs
- mibavademab
- Conditions
- generalized lipodystrophy (GL)
01
Overview
Phase 3, open-label, single-arm trial of mibavademab in generalized lipodystrophy (GL), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Incidence of treatment-emergent adverse events at 68 weeks and Severity of treatment-emergent adverse events at 68 weeks. Started Dec 2024; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
mibavademab
Patients switching from at least 6 months of therapy with metreleptin to mibavademab.
03
Who it enrols
Patients with congenital or acquired generalized lipodystrophy who have been treated with a stable dose of metreleptin for at least 6 months, with stable diet and diabetes/dyslipidemia medications. Excludes patients with recent weight loss medications, chronic high-dose corticosteroids, recent malignancies, severe renal impairment (eGFR <30), or recent significant cardiovascular events.
04
Endpoints
Primary
Incidence of treatment-emergent adverse events
Severity of treatment-emergent adverse events
Secondary
Change in Hemoglobin A1c
Occurrence of HbA1c <7%
Occurrence of HbA1c <6.5%
Occurrence of requiring therapy with insulin
Change in total insulin dose
Change in fasting plasma glucose
Percent change in fasting triglycerides
Occurrence of fasting triglycerides <500 mg/dL
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