A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients with Generalized Lipodystrophy

Generalized Lipodystrophy

For Part A only: Change in Hemoglobin A1c (HbA1c), For Part A only: Percent change in fasting Triglycerides (TG), For Part B only: Occurrence of Treatment Emergent Adverse Events (TEAEs), For Part B only: Severity of TEAEs, For Part B only: Concentrations of total mibavademab in serum

For Part A only: Change in HbA1c compared to placebo, For Part B only: Change in HbA1c, For Part A only: Percent change in fasting TG compared to placebo, For Part B only: Percent change in fasting TG, For Part A only: Occurrence of HbA1c <7%, For Part A only: Occurrence of HbA1c <6.5%, For Part A only: Occurrence of fasting TG <500 mg/dL, For Part A only: Occurrence of fasting TG <200 mg/dL, For Part A only: Occurrence of fasting TG <150 mg/dL, For Part A only: Percent change in Liver Fat Content (LFC), For Part A only: Change in liver volume, For Part A only: Change in fasting glucose, Change in total daily insulin dose, For Part A only: Concentrations of total mibavademab in serum, Occurrence of anti-drug antibodies (ADA) to mibavademab, Titer of ADA to mibavademab, For Part A only: Occurrence of TEAEs, For Part A only: Severity of TEAEs

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