At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 77 enrolled
Drug / intervention
Setmelanotide +3 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 Randomized, Double-Blind, 3-arm, Parallel Group, Placebo- and Positive-controlled Study to Investigate the Effects of Setmelanotide on QTc Interval in Healthy Subjects
In Brief
A Phase 4 clinical trial evaluating Setmelanotide, Moxifloxacin, and 2 other interventions for Healthy. Completed, enrolled 77 participants across 1 site.
Detailed Summary
This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
Enrollment StartAug 2021
First PostedSep 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedSep 16, 2021
Enrollment StartAug 5, 2021
Primary CompletionApr 7, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.8 years ago
Interventions
Setmelanotidedrug
Administered once daily via SC injection.
Moxifloxacindrug
Moxifloxacin capsules via oral administration.
Oral Placebodrug
Placebo capsules via oral administration.
SC Placebodrug
Placebo via SC injection.