NCT02311673

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

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: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the effects of a once daily subcutaneous injectable formulation of setmelanotide in obese participants with Prader-Willi syndrome on tolerability, weight loss, and hyperphagia-related behavior. The study drug (setmelanotide and placebo) was administered in a blinded fashion.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Setmelanotide	subcutaneous injection
DRUG	Placebo	Subcutaneous injection

Timeline

• Start date: 2015-03-19
• Primary completion: 2016-10-26
• Completion: 2016-10-26
• First posted: 2014-12-08
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study