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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection
National Institutes of Health
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to week 68
Severity of TEAEs
Time frame: Up to week 68
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, week 20 and week 52
Occurrence of HbA1c <7%
Time frame: Week 20 and week 52
Occurrence of HbA1c <6.5%
Time frame: Week 20 and week 52
Occurrence of requiring therapy with insulin in participants treated with mibavademab
Time frame: Week 20 and week 52
Change in total insulin dose
Time frame: Baseline, week 20 and week 52
Change in fasting plasma glucose
Time frame: Baseline, week 20 and week 52
Percent change in fasting triglycerides
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Concentrations of total mibavademab in serum
Time frame: Up to week 68
Incidence of anti-drug antibodies (ADAs) to mibavademab
Time frame: Up to week 68
Titer of ADAs to mibavademab
Time frame: Up to week 68
Incidence of neutralizing antibodies (Nabs) to mibavademab
Time frame: Up to week 68
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