Phase 3
Completed N=60
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
Polycystic Ovary Syndrome · Adolescent Obesity · Non-Alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov NCT03919929 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Change in Hepatic Fat Fraction — -1.41; -1.84 Change in percentage of liver fat
◆ Published Evidence
Not yet cited
0citations
Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity.
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.
Linked Publications
-
Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.