NCT03919929

Treating PCOS With Semaglutide vs Active Lifestyle Intervention

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In obese girls with polycystic ovarian syndrome, testosterone and obesity combine to create unique pathology to increase metabolic disease including fatty liver and insulin resistance, which may be mediated by altered glucagon like peptide-1 activity. The investigators will treat girls with obesity and polycystic ovarian syndrome for 4 months with a glucagon like peptide-1 receptor agonist compared to dietary intervention to primarily lower hepatic fat and secondarily improve whole body and adipose insulin sensitivity. Mechanisms of hepatic metabolism, including rates of de novo lipogenesis and relative mitochondrial flux will also be assessed.

Conditions

• PCOS
• Adolescent Obesity
• NAFLD

Interventions

Type	Name	Description
DRUG	Semaglutide 3mg and 7mg [Rybelsus]	Once daily oral tablet of semaglutide for 4 months
OTHER	Weight loss diet	Prescribed weight loss diet to match weight loss in Drug arm

Timeline

• Start date: 2019-05-03
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2019-04-18
• Last updated: 2025-11-25
• Results posted: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study