At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Semaglutide 3mg and 7mg [Rybelsus] +1 moredrug
Likely dose
Semaglutide 3mg and 7mg [Rybelsus]from 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.
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
In Brief
A Phase 3 clinical trial evaluating Semaglutide 3mg and 7mg [Rybelsus] and Weight loss diet for PCOS and 2 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Girls with obesity and polycystic ovarian syndrome will receive either glucagon like peptide-1 receptor agonist therapy or a dietary intervention for 12 weeks to decrease the metabolic syndrome, in particular to lower hepatic fat and improve insulin sensitivity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPCOS, Adolescent Obesity, NAFLD
CountriesUnited States
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartMay 2019
Primary CompletionOct 2023
TodayJul 2026
First PostedApr 18, 2019
Enrollment StartMay 3, 2019
Primary CompletionOct 3, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.2 years ago
Interventions
Semaglutide 3mg and 7mg [Rybelsus]drug
Once daily oral tablet of semaglutide for 4 months
Weight loss dietother
Prescribed weight loss diet to match weight loss in Drug arm