Phase 3
N=60
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
PCOS · Adolescent Obesity · NAFLD
Bottom Line
View on ClinicalTrials.gov: NCT03919929 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Hepatic Fat Fraction — -1.41; -1.84 Change in percentage of liver fat
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide 3mg and 7mg [Rybelsus] (Drug); Weight loss diet (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hepatic Fat Fraction |
-1.41; -1.84 | — |
| PRIMARY Change in Weight |
-1.66; -5.30 | — |
| SECONDARY Change in Rate of De Novo Lipogenesis (DNL) |
0.94; -1.9 | — |
| SECONDARY Change in Whole Body Insulin Sensitivity |
0.0000629; 0.000213 | — |
| SECONDARY Change in Adipose Insulin Sensitivity |
0.44; -1.431 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
- BMI equal or greater than the 90th percentile for age and gender
- PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >12 months post-menarche and clinical or biochemical hypertestosteronemia
- Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g. copper IUD) for the entire study period. For participants who receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication.
Exclusion Criteria
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening.
- Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening), oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal contraception (cannot have been used in the 6 months prior to screening). Dermal patch or vaginal ring contraception methods.Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- Severe illness requiring hospitalization within 60 days.
- Diabetes, defined as Hemoglobin A1C > 6.4%
- BMI percentile less than the 90th percentile for age and sex. Weight >325 lbs. or 100 IU/L.
- Personal history of pancreatitis
- Known renal disease of any severity or an eGFR at screening of <45ml/min/1.73m2
- History of severe GI disease (e.g. gastroparesis)
- History of gallstones
- Untreated thyroid disease
- History of hypersensitivity to semaglutide
- Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma).
- Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder
Data sourced from ClinicalTrials.gov (NCT03919929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.