17% weight loss in 4 months! "Hypothalamic obesity" treatment may usher in a "new weapon"

According to news from relevant pharmaceutical companies, the US Food and Drug Administration (FDA) has granted setmelanotide breakthrough therapy designation for the treatment of hypothalamic obesity
.
In the Phase 2 trial, the drug reduced body mass index (BMI) by an average of 17.
2%
in people with hypothalamic obesity in just 16 weeks.

What is hypothalamic obesity?

Obesity is an important chronic disease that threatens human health in today's society, and in-depth understanding of the pathogenesis of obesity and finding safe and effective treatment methods are the main problems
facing medicine.
In recent years, numerous studies have shown that the central nervous system, especially the hypothalamus, plays an important role
in the regulation of energy homeostasis.

The hypothalamus can receive peripheral hormone and nutrient afferent signals, integrate with other parts of the central nervous system to transmit human signals, and regulate feeding behavior and energy expenditure through outgoing signals, so as to promote the body to achieve energy balance
.
Structural or functional abnormalities of the hypothalamic energy regulation pathway can lead to hyperphagia and rapid progressive weight gain, that is, hypothalamic obesity
.
Among them, hyperphagia is one of the most important clinical features of
hypothalamic obesity.

Due to the complex role of the hypothalamus in the regulation of energy homeostasis, hypothalamic obesity is still a difficult point in clinical treatment
.

What does it mean to be approved for Breakthrough Therapy?

For example, the senior management experts of the US FDA will intervene in the clinical development process, will advise on the design of clinical trials, and answer various questions in various stages of clinical trials in a timely manner, most of which can be answered within
60 days.
Save and shorten lead time
with fast, rolling follow-up of new drug applications (NDAs) after clinical trials end.

Hypothalamic obesity treatment is about to usher in a "new weapon"

The approval of breakthrough therapy designation is based on the results of a 16-week Phase 2 clinical study by setmelanotide that showed a reduction in BMI of more than 5% at 16 weeks in all 11 patients, with an average reduction of 17.
2%.

Resources:

[1] FDA grants breakthrough therapy designation to setmelanotide for hypothalamic obesity.
2022-11-02.
com/news/endocrinology/20221102/fda-grants-breakthrough-therapy-designation-to-setmelanotide-for-hypothalamic-obesity

[2] WU Wei, YANG Yehong, LI Yiming.
Clinical research progress in hypothalamic obesity.
International Journal of Endocrinology and Metabolism.
2014,34(1): 32-35.
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3760/cma.
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issn.
1673-4157.
2014.
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