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 mutations

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 mutations

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2018

At a glance

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

    • 23 Jul 2018 Status changed from recruiting to active, no longer recruiting, as reported in a Rhythm Pharmaceuticals media release.
    • 14 Jun 2018 According to a Rhythm Pharmaceuticals media release, the company plans to file a New Drug Application (NDA) with the FDA for setmelanotide based on one-year data from a pivotal cohort of 10 patients.
    • 14 Jun 2018 According to a Rhythm Pharmaceuticals media release, the company expects to report initial data from this trial in the third quarter of 2019.
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