A Ph 2, Randomized, Double-Blind, Placebo-controlled Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related Behaviors

Trial Profile

A Ph 2, Randomized, Double-Blind, Placebo-controlled Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related Behaviors

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Apr 2017

At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Prader-Willi syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Rhythm
  • Most Recent Events

    • 03 Jan 2017 Status changed from recruiting to completed.
    • 07 Jan 2016 According to a Rhythm media release, the US FDA granted orphan drug designation for setmelanotide (RM-493) for the treatment of Prader-Willi syndrome (PWS). The company plans to complete this trial in the H1 2016.
    • 03 Aug 2015 Planned End Date changed from 1 Sep 2015 to 1 Oct 2017 as per ClinicalTrials.gov
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