Treating PCOS With Semaglutide vs Active Lifestyle Intervention

NCT03919929 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of semaglutide, a medication, to an active lifestyle intervention on liver fat in adolescents with polycystic ovary syndrome (PCOS), obesity, and non-alcoholic fatty liver disease (NAFLD).

Status Completed The study has finished.

Phase Phase2, Phase3

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 60 people

Who can join Ages 12–21 · female only

Timeline Started 2019-05 · est. completion 2023-10

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03919929 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide 3mg and 7mg [Rybelsus] also known as GLP-1 receptor agonist Drug

Once daily oral tablet of semaglutide for 4 months
Weight loss diet Other

Prescribed weight loss diet to match weight loss in Drug arm

Main thing measured	Change in Hepatic Fat Fraction
Sponsor	University of Colorado, Denver
Conditions studied	PCOS, Adolescent Obesity, NAFLD
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03919929 ↗