Trial Profile

A Phase 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

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 28 Nov 2025

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At a glance

04 Nov 2025 According to a Rhythm media release, the company is on track to report preliminary results from setmelanotide Phase 2 trial in Prader-Willi syndrome in fourth quarter of 2025.
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.

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