drugset / Trial / NCT02041195

Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

NCT02041195

Phase 1/2 Completed 99 enrolled Rhythm Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2014-01
Primary completion
2014-08
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Setmelanotide Protein / enzyme biologic Subcutaneous

Indications