Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

Summary

The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and ambulatory blood pressure in obese participants. The study is designed to evaluate the efficacy and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion.

Timeline

Start

2013-01-14

Primary completion

2013-09-28

Completion

2013-09-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Setmelanotide vs Placebo; p = 0.059; Treatment Difference -1.1 (95% CI -2.27 to 0.04); Mixed Model Repeated Measures (MMRM) NCT01749137 ↗

Drugs

Indications