A Staged, Phase 1b/Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients Using a Once or Twice Daily Sub-Cutaneous Injection Formulation

Unknown Phase 1,Phase 2 NCT02041195

Study Description

The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

Study Details

Registry ID:: NCT02041195
Conditions:: Overweight and Obesity
Phase:: Phase 1,Phase 2
Target Enrollment:: 99 participants
Start Date:: January 1, 2014
Healthy Volunteers:: No

Study Locations (2 sites)

Madison, WisconsinUnited States, United States
Dallas, TexasUnited States, United States

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