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
Phase of Trial: Phase II
Latest Information Update: 12 Feb 2018
At a glance
- Drugs Setmelanotide (Primary)
- Indications Prader-Willi syndrome
- Focus Adverse reactions; Therapeutic Use
- Sponsors Rhythm
- 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