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An Open-Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation

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Trial Profile

An Open-Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Obesity
  • Focus Therapeutic Use
  • Sponsors Rhythm

Most Recent Events

  • 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.
  • 23 Mar 2021 Results from NCT02507492, NCT02896192 and NCT03287960 evaluating onset of adverse events in patients with POMC/PCSK1 or LEPR deficiency obesity treated with setmelanotide, presented at the 103rd Annual Meeting of the Endocrine Society
  • 09 Mar 2021 According to a Rhythm Pharmaceuticals media release, data from this study will be presented by Karine Clement at the 103rd Annual Meeting and Expo of the Endocrine Society (ENDO 2021).

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