Trial Profile

A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 25 Dec 2024

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At a glance

20 Dec 2024 According to a Rhythm media release, the FDA has approved IMCIVREE (setmelanotide) for children aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed POMC, PCSK1, or LEPR deficiency.
27 Nov 2024 Status changed from active, no longer recruiting to completed.
18 Nov 2024 According to a Rhythm media release, A cross-sectional analysis of 50 patients aged 2 to 17 years, with rare MC4R pathway diseases who participated in one of five different clinical trials of setmelanotide, including this one, was presented at European Society for Paediatric Endocrinology (ESPE 2024), held Nov 16-18, 2024, at Liverpool, UK.

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