At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 205 enrolled
Drug / intervention
Setmelanotidedrug
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.
Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway
In Brief
A Phase 3 clinical trial evaluating Setmelanotide for Obesity Associated With Defects in Leptin-melanocortin Pathway. Completed, enrolled 205 participants across 27 sites in 8 countries.
Detailed Summary
This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Greece, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
First PostedAug 2018
Primary CompletionJan 2025
TodayJul 2026
First PostedAug 29, 2018
Enrollment StartJul 15, 2018
Primary CompletionJan 9, 2025
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 7.8 years ago
Interventions
Setmelanotidedrug
Once daily subcutaneous injection