drugset
drugset / Trial / NCT02311673

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

NCT02311673 ↗

Phase 2 Completed 40 enrolled Rhythm Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-03-19
Primary completion
2016-10-26
Completion
2016-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Setmelanotide Protein / enzyme biologic 0.5 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 1.5 mg Subcutaneous
Subject Setmelanotide Protein / enzyme biologic 2.5 mg Subcutaneous

Indications

Prader-Willi syndrome