At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 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.
A Phase 3 Multi-Center, 1-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity
In Brief
A Phase 3 clinical trial evaluating Setmelanotide for Bardet-Biedl Syndrome and 3 related conditions. Completed, enrolled 12 participants across 6 sites in 4 countries.
Detailed Summary
This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genes or Bardet-Biedl Syndrome (BBS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBardet-Biedl Syndrome, POMC Deficiency Obesity, PCSK1 Deficiency Obesity, LEPR Deficiency Obesity
CountriesAustralia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartMar 2022
Primary CompletionSep 2023
Study CompletionNov 2024
TodayJul 2026
First PostedJul 19, 2021
Enrollment StartMar 8, 2022
Primary CompletionSep 18, 2023
Study CompletionNov 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.0 years ago
Interventions
Setmelanotidedrug
SC injection once daily.