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Treating PCOS With Semaglutide vs Active Lifestyle Intervention

NCT03919929 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-25

Study results available
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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.

Conditions

  • PCOS
  • Adolescent Obesity
  • NAFLD

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Melanie Cree-Green, MD, PhD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919929 on ClinicalTrials.gov