At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 74 enrolled
Drug / intervention
Setmelanotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Setmelanotide and Placebo for Overweight. Completed, enrolled 74 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartJan 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedDec 13, 2012
Enrollment StartJan 14, 2013
Primary CompletionSep 28, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.6 years ago
Interventions
Setmelanotidedrug
Daily subcutaneous infusion
Placebodrug
Daily subcutaneous infusion