At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 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 Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related Behaviors
In Brief
A Phase 2 clinical trial evaluating Setmelanotide and Placebo for Prader-Willi Syndrome. Completed, enrolled 40 participants across 5 sites.
Detailed Summary
The purpose of this study was to evaluate the effects of a once daily subcutaneous injectable formulation of setmelanotide in obese participants with Prader-Willi syndrome on tolerability, weight loss, and hyperphagia-related behavior. The study drug (setmelanotide and placebo) was administered in a blinded fashion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartMar 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedDec 8, 2014
Enrollment StartMar 19, 2015
Primary CompletionOct 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.6 years ago
Interventions
Setmelanotidedrug
subcutaneous injection
Placebodrug
Subcutaneous injection