NCT04966741

Who might be able to join this trial:

• The child has obesity caused by a specific genetic condition — either a confirmed change in the POMC, PCSK1, or LEPR gene, or a confirmed diagnosis of Bardet-Biedl Syndrome (BBS), shown through genetic testing.
• The child is between 2 and 5 years old (must not have turned 6 yet) at the time of signing up.
• The child has a BMI at or above the 97th percentile for their age and gender, and weighs at least 15 kilograms (about 33 pounds).
• The child shows signs of extreme, hard-to-control hunger (known as hyperphagia).
• A parent or guardian is able to understand and follow all study requirements, including giving a daily injection, and is able to sign the consent forms.

Who may not be able to join:

• The child has a blood sugar control reading (HbA1c) above 9.0% at the screening visit.
• The child has a significant history of liver disease.
• The child's kidneys are not filtering blood well enough (confirm with trial site for exact values).
• The child or a close family member has a history of melanoma (a type of skin cancer), or the child has a condition called oculocutaneous albinism.
• The child has significant skin findings related to melanoma or pre-cancerous skin lesions (certain minor skin conditions may be exceptions — confirm with trial site).
• The child has taken part in another clinical trial involving an experimental drug or device within the past 3 months.
• The child has previously been in a study involving the drug being tested in this trial (setmelanotide), or has taken setmelanotide before.
• The child has a significant allergy or sensitivity to any ingredient in the study drug.
• The child has poor liver function.
• The child has another uncontrolled health or hormonal condition known to affect body weight.

Important: Always verify eligibility with the trial site directly before applying.