A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults

Exclusion Criteria

• •1. Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
• •2. History of bariatric surgery within approximately the past 12 months of study screening
• •3. History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
• •4. History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
• •5. History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug
• •6. Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation
• •7. Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
• •8. Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol