drugset / Trial / NCT02041195
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Setmelanotide | Protein / enzyme biologic | — | Subcutaneous |