Clinical Trial

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

Study acronym: RESTORE
Recruiting Phase 3
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Summary
Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-04-06; most recent amendment 2025-08-21.
Status change: Not Yet Recruiting → Recruiting 2023-11-21
Trial Details
NCT Number NCT05819853
Lead Sponsor University of Colorado, Denver
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese
Enrollment 80 participants
Start Date 2023-11-03
Primary Completion 2028-02-01 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-28