A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Prior treatment

• Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years
• Bariatric surgery or procedure within last 2 years
• Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
• Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
• If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

• 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
• Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
• History or close family history of skin cancer or melanoma

Other

• Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
• Inability to comply with once daily (QD) injection regimen
• If female, pregnant and/or breastfeeding.

• Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg/m2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to \<18 years
• Age 4 years and older
• Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \<18 years of age
• Agree to use a highly effective form of contraception throughout the study and for 90 days after the study