At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Setmelanotide 2 mg +5 moredrug
Likely dose
Setmelanotide 2 mgfrom 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 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) With a Crossover to Open-Label Once Weekly Setmelanotide in Patients With Specific Gene Defects in the Melanocortin-4 Receptor Pathway Who Are Currently on a Stable Dose of the Once Daily Formulation
In Brief
A Phase 3 clinical trial evaluating Setmelanotide 2 mg, Setmelanotide 2.5 mg, and 4 other interventions for Bardet-Biedl Syndrome and POMC Deficiency. Completed, enrolled 19 participants across 7 sites in 6 countries.
Detailed Summary
A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBardet-Biedl Syndrome, POMC Deficiency
CountriesCanada, Germany, Netherlands, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartDec 2021
First PostedJan 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedJan 18, 2022
Enrollment StartDec 21, 2021
Primary CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.5 years ago
Interventions
Setmelanotide 2 mgdrug
Administered as SC injection
Setmelanotide 2.5 mgdrug
Administered as SC injection
Setmelanotide 3 mgdrug
Administered as SC injection
Setmelanotide 20 mgdrug
Administered as SC injection
Setmelanotide 25 mgdrug
Administered as SC injection
Setmelanotide 30 mgdrug
Administered as SC injection