NCT01749137

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

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (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 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.

Conditions

• Overweight

Interventions

Type	Name	Description
DRUG	Setmelanotide	Daily subcutaneous infusion
DRUG	Placebo	Daily subcutaneous infusion

Timeline

• Start date: 2013-01-14
• Primary completion: 2013-09-28
• Completion: 2013-09-28
• First posted: 2012-12-13
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study