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

Key Inclusion Criteria:

1. Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitaryhormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with atleast 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 <18years

2. Age 4 years and older

3. 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 4 to <18 years of age

4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study

Key Exclusion Criteria:

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

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 3months prior to the first trial dose

9. Previously enrolled in a clinical trial involving setmelanotide or any previousexposure to setmelanotide

10. Inability to comply with once daily (QD) injection regimen

11. If female, pregnant and/or breastfeeding.

12. If receiving hormone replacement therapy, dose has remained stable for at least 2months before Screening

Other protocol defined Inclusion/Exclusion criteria may apply.