A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Exclusion Criteria

• •1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
• •2. 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
• •3. Bariatric surgery or procedure within last 2 years
• •4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
• •5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
• •6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
• •7. History or close family history of skin cancer or melanoma
• •8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
• •9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
• •10. Inability to comply with once daily (QD) injection regimen
• •11. If female, pregnant and/or breastfeeding
• •12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL \[POMC, PCSK1, LEPR, collectively\], BBS) prior to the hypothalamic injury.
• •13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening