Treating PCOS With Semaglutide vs Active Lifestyle Intervention

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03919929
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Adolescent Obesity
  • NAFLD
  • PCOS

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 3mg and 7mg [Rybelsus] — 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

Study Details

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.

Key Dates

Start date
May 3, 2019
Status verified
Nov 2025
Primary completion
Oct 3, 2023
Completion
Oct 3, 2023

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Diet Intervention
    Weight loss with dietary intervention
  • Experimental: GLP-1 Intervention
    Participants will take a daily oral tablet of semaglutide for 4 months.

Primary Outcome Measure

Change in Hepatic Fat Fraction [ Time Frame: Baseline and 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anshutz Medical Campus/Children's Hospital ColoradoAuroraColorado80045-

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University of Colorado Anshutz Medical Campus/Children's Hospital Colorado· Aurora, CO

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