A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity

Prior treatment

• Weight loss \>2% in the previous 3 months for participants ≥18 years of age or \>2% reduction in BMI for participants \<18 years of age
• Previous use of MC4R agonists

Other illness

• History of major surgical procedure within 30 days
• Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
• Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
• History or close family history of skin cancer or melanoma
• Clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Lab values

• HbA1c \>10.9%
• Fasting glucose level \>270 mg/dL

• Documented evidence of acquired hypothalamic obesity (HO)
• Age 12 years and older
• Weight gain associated with the hypothalamic injury and a body mass index (BMI) of ≥30 kg/m\^2 for participants ≥18 years of age or BMI ≥95th percentile for age and sex for participants \<18 years of age
• Male and female participants agreed to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study