Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

Inclusion Criteria

• •1. Participants with the following genotypes and/or clinical assessment:
• •1. POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants
• •2. POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity
• •3. POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity
• •4. SMS
• •5. SH2B1 deficiency obesity
• •6. Chromosomal rearrangement of the 16p11.2 locus causing obesity
• •7. Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity
• •8. Leptin deficiency obesity with loss of response to metreleptin
• •9. SRC1 deficiency obesity
• •10. MC4R deficiency obesity
• •2. Age 6 years and above
• •3. Obese, defined as Body Mass Index (BMI) ≥ 30 kilogram per meter square (kg/m\^2) for participants ≥16 years of age or BMI≥ 95th percentile for age and gender for participants 6 up to 16 years of age.
• •4. Participant and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
• •5. Female participants of childbearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol.
• •6. Male participants with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study. Male participants must not donate sperm during and for 90 days following their participation in the study.