Long Term Extension Trial of Setmelanotide

This is an interventional treatment trial for Obesity Associated With Defects in Leptin-melanocortin Pathway focused on measuring setmelanotide, RM-493, obesity, leptin-melanocortin, melanocortin 4 receptor Read More

Key Inclusion Criteria:

1. Patients aged 2 or older who have completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)
2. Patient and/or parent or guardian is able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements
3. Agree to use a highly effective form of contraception throughout the trial

Key Exclusion Criteria:

1. Pregnant and/or breastfeeding women
2. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
3. Current, clinically significant disease
4. Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
5. Suicidal ideation, attempt or behavior
6. History of significant liver disease
7. Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR) <30 mL/min.
8. History or close family history of melanoma or patient history of oculocutaneous albinism

Other protocol defined Inclusion/Exclusion criteria may apply.