NCT05819853

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Polycystic ovary syndrome is one of the most common endocrinopathies in women, presents with anovulation in adolescence, and reproductive dysfunction is related to excess weight. After a 4-month observation period of either no medication or metformin treatment, females aged 12-35 years with obesity and polycystic ovary syndrome will receive 10 months of a glucagon-like peptide-1 receptor agonist to induce metabolic changes, weight loss and improve reproductive abnormalities. We will assess the relationship between weight loss and reproductive function, as well as identify if age, hormonal and metabolic measures and such insulin sensitivity and insulin secretion predict the response to glucagon-like peptide-1 receptor agonist therapy.

Conditions

• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Obese

Interventions

Type	Name	Description
DRUG	Semaglutide Injectable Product (Wegovy and/or Ozempic)	10 months of semaglutide, with dose escalation as recommended by manufacturer. Maximum dose used will be 1.7mg

Timeline

• Start date: 2023-11-03
• Primary completion: 2028-02-01
• Completion: 2028-06-30
• First posted: 2023-04-19
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study