A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Key Inclusion Criteria: Documented evidence of acquired hypothalamic obesity (HO) 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 Key Exclusion Criteria: Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET) 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 Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) History or close family history of skin cancer or melanoma 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 Inability to comply with once daily (QD) injection regimen If female, pregnant and/or breastfeeding Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL [POMC, PCSK1, LEPR, collectively], BBS) prior to the hypothalamic injury. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening Other protocol defined Inclusion/Exclusion criteria may apply.