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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 Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR 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 Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 May 2023

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At a glance

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

    • Most Recent Events

    • 14 Oct 2021 Results of post-hoc analyses published in the Rhythm Media Release.
    • 14 Oct 2021 According to a Rhythm media release, results of post-hoc analyses presented at the Obesity Medicine Association's Overcoming Obesity 2021 Conference and its Digital Experience (DX).
    • 21 Sep 2021 According to a Rhythm Pharmaceuticals media release, the Great Britain Medicines & Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to IMCIVREE for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin, including proprotein convertase subtilisin/kexin type 1, deficiency or biallelic leptin receptor deficiency in adults and children 6 years of age and above.
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