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 Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation
In Brief
A Phase 3 clinical trial evaluating Setmelanotide and Placebo for Leptin Receptor Deficiency Obesity. Completed, enrolled 15 participants across 6 sites in 6 countries.
Detailed Summary
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the end of 1 year of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeptin Receptor Deficiency Obesity
CountriesCanada, France, Germany, Netherlands, Reunion, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartJan 2018
Primary CompletionSep 2020
TodayJul 2026
First PostedSep 19, 2017
Enrollment StartJan 30, 2018
Primary CompletionSep 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.8 years ago
Interventions
Setmelanotidedrug
Once daily subcutaneous injection
Placebodrug
Once daily subcutaneous injection