Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy

Exclusion Criteria

• •1. Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus
• •2. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol
• •3. eGFR of \<30 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once
• •4. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol
• •5. Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit
• •For Part A only:
• •1. Treatment with metreleptin within 3 months of the screening visit
• •2. Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and/or dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol
• •3. Significant changes to lifestyle and diet, as described in the protocol
• •4. Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol