Mibavademab
DrugAdministered by intravenous (IV) infusion followed by subcutaneous (SC) injection
Other names: REGN4461
NCT Number: NCT06548100
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.
The study is looking at several other research questions, including:
* What side effects may happen from taking mibavademab * How much mibavademab is in the blood at different times * Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)
This study is active but is not currently recruiting participants.
Notify Me2 year and older
All sexes
Interventional
Phase 3
National Institutes of Health, Bethesda, Maryland, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion / exclusion criteria apply
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection
Other names: REGN4461
Time frame: Up to week 68
Time frame: Up to week 68
Time frame: Baseline, week 20 and week 52
Time frame: Week 20 and week 52
Time frame: Week 20 and week 52
Time frame: Week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Baseline, week 20 and week 52
Time frame: Up to week 68
Time frame: Up to week 68
Time frame: Up to week 68
Time frame: Up to week 68
Regeneron Pharmaceuticals
Industry
A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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