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

Prior treatment

• Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening.
• 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.
• Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening.
• Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol.

Other illness

• History of bariatric surgery within approximately the past 12 months of study screening.
• History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening.
• History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene.
• 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.

Other

• NOTE: Other Protocol-defined exclusion criteria apply.

• Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit.
• Has class ≥2 obesity at screening and at baseline, as defined in the protocol.
• NOTE: Other Protocol-defined inclusion criteria apply.