At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15 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.
An Open-Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation
In Brief
A Phase 3 clinical trial evaluating Setmelanotide and Placebo for Pro-opiomelanocortin (POMC) Deficiency Obesity. Completed, enrolled 15 participants across 7 sites in 7 countries.
Detailed Summary
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with pro-opiomelanocortin (POMC) deficiency or proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity due to rare biallelic or loss-of function mutations at the end of 1 year of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, France, Germany, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartFeb 2017
Primary CompletionMay 2020
TodayJul 2026
First PostedSep 12, 2016
Enrollment StartFeb 14, 2017
Primary CompletionMay 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.8 years ago
Interventions
Setmelanotidedrug
Once daily SC injection
Placebodrug
Once daily SC injection