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

Key Inclusion Criteria:

• Documented evidence of acquired hypothalamic obesity (HO)

• Age 12 years and older

• Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 forpatients ≥18 years of age or BMI ≥95th percentile for age and sex for patients <18years of age

• Male and female participants agree to follow study contraception requirements anduse a highly effective form of contraception throughout the study and for 90 daysafter the study

Key Exclusion Criteria:

• Weight loss >2% in the previous 3 months for patients ≥18 years of age or >2%reduction in BMI for patients <18 years of age

• History of major surgical procedure within 30 days

• HbA1c >10.9%

• Fasting glucose level >270 mg/dL

• Previous use of MC4R agonists

• Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity withhypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumorsyndrome (ROHHADNET).

• Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt orbehavior

• History or close family history of skin cancer or melanoma

• Current clinically significant pulmonary, cardiac, or oncologic disease consideredsevere enough to interfere with the study and/or confound the results

Other protocol defined Inclusion/Exclusion criteria may apply.