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Setmelanotide is a medication that has recently been approved for the treatment of obesity caused by certain genetic conditions. It is a melanocortin-4 receptor agonist that helps to regulate hunger and satiety signals, which can lead to weight loss in patients with specific genetic mutations.

FDA approval

Setmelanotide was approved by the US Food and Drug Administration (FDA) in November 2020 for the treatment of obesity caused by proopiomelanocortin (POMC) deficiency, proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency. These genetic mutations can lead to a lack of satiety signals, which can result in overeating and obesity.


In clinical trials, patients with POMC or PCSK1 deficiency who received setmelanotide experienced significant weight loss compared to the placebo group.


In the POMC deficiency trial, patients lost an average of 26.7 pounds over 52 weeks, while in the PCSK1 deficiency trial, patients lost an average of 15.7 pounds over 26 weeks. In the LEPR deficiency trial, however, the drug did not meet its primary endpoint.


Setmelanotide is administered as an injection under the skin, usually once a day.

Limited use

It is important to note that this medication is not intended for use in patients with obesity due to lifestyle or environmental factors, and it should only be used under the guidance of a healthcare professional who specializes in the treatment of obesity.

Side effects

As with any medication, setmelanotide can cause side effects, including injection site reactions, nausea, vomiting, and headache. It is important to discuss the risks and benefits of this medication with a healthcare provider before starting treatment.

How can W8MD help?

At W8MD Weight Loss, Sleep & MedSpa centers, our experienced physicians can help evaluate patients for obesity due to genetic factors and determine whether setmelanotide may be an appropriate treatment option. We offer a comprehensive approach to weight loss, including personalized diet plans, exercise recommendations, and medication management. Contact us today to learn more.


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W8MD Weight Loss, Sleep & Medspa Centers

W8MD Weight Loss, Sleep & Medspa Centers is a network of medical centers located in New York, Pennsylvania, New Jersey and surrounding areas that provide comprehensive care for weight loss, sleep disorders, and aesthetic treatments.

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