NCT02041195

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Setmelanotide
DRUG	Placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2014-01-20
• Last updated: 2023-08-07
• Results posted: 2023-08-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study