At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 99 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 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
In Brief
A Phase 2 clinical trial evaluating Setmelanotide and Placebo for Overweight and Obesity. Completed, enrolled 99 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight and Obesity
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionAug 2014
Study CompletionDec 2014
TodayJul 2026
First PostedJan 20, 2014
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.5 years ago
Interventions
Setmelanotidedrug
Placebodrug