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

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

Outcome

Missed primary endpoint

registry Setmelanotide 1.5 mg (Double-blind Randomized Treatment) vs Placebo (Double-blind Randomized Treatment); p = 0.348; LS Mean Difference -0.4 (95% CI -2.3 to 1.6) NCT02311673 ↗

registry Setmelanotide 1.5 mg (Double-blind Randomized Treatment) vs Placebo (Double-blind Randomized Treatment); p = 0.362; LS Mean Difference -3.9 (95% CI -26.3 to 18.5) NCT02311673 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
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