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TEAL
CompletedPhase 2, PHASE3Results postedTreating PCOS With Semaglutide vs Active Lifestyle Intervention
Lead sponsor
Asset
Semaglutide
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
60
actual
Study population
Obesity / overweight, PCOS
Key I/E criterion
•Female
Primary endpoints
•Liver fat content, change•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
2. BMI equal or greater than the 90th percentile for age and gender
3. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >12 months post-menarche and clinical or biochemical hypertestosteronemia
4. 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
1. 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.
2. 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.
3. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
4. Severe illness requiring hospitalization within 60 days.
5. Diabetes, defined as Hemoglobin A1C > 6.4%
6. BMI percentile less than the 90th percentile for age and sex. Weight >325 lbs. or <84 lbs.
7. Anemia, defined as Hemoglobin < 11 mg/dL
8. Diagnosed major psychiatric or developmental disorder limiting informed consent.
9. Implanted metal devices that are not compatible with MRI
10. Use of blood pressure medications.
11. Known liver disease other than NAFLD or AST or ALT >100 IU/L.
12. Personal history of pancreatitis
13. Known renal disease of any severity or an eGFR at screening of <45ml/min/1.73m2
14. History of severe GI disease (e.g. gastroparesis)
15. History of gallstones
16. Untreated thyroid disease
17. History of hypersensitivity to semaglutide
18. Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma).
19. Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in Weight
Time frame:Baseline and 12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Change in weight (KG) | 95% CI |
|---|---|---|
| Diet Intervention | -1.66 | — |
| GLP-1 Intervention | -5.30 | — |
Change in Weight
Time frame:Baseline and 12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange in Whole Body Insulin Sensitivity
Time frame:Baseline and 12 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), dl/kg/min per microU/ml | 95% CI |
|---|---|---|
| Diet Intervention | 0.0000629 | — |
| GLP-1 Intervention | 0.000213 | — |
Change in Adipose Insulin Sensitivity
Time frame:Baseline and 12 weeks
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage of change | 95% CI |
|---|---|---|
| Diet Intervention | 0.44 | — |
| GLP-1 Intervention | -1.431 | — |
Change in Whole Body Insulin Sensitivity
Time frame:Baseline and 12 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Change in Adipose Insulin Sensitivity
Time frame:Baseline and 12 weeks
change from baseline, improvement
MASH / liver
3 endpointsChange in Hepatic Fat Fraction
Time frame:Baseline and 12 weeks
Liver fat content, change
change from baseline, improvement
Posted result
| Group | Value (mean), Change in percentage of liver fat | 95% CI |
|---|---|---|
| Diet Intervention | -1.41 | — |
| GLP-1 Intervention | -1.84 | — |
Change in Hepatic Fat Fraction
Time frame:Baseline and 12 weeks
Liver fat content, change
change from baseline, improvement
Change in Rate of De Novo Lipogenesis (DNL)
Time frame:Baseline and 12 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Diet Intervention | 0.94 | — |
| GLP-1 Intervention | -1.9 | — |
Cardiometabolic biomarkers
1 endpointChange in Rate of De Novo Lipogenesis (DNL)
Time frame:Baseline and 12 weeks
change from baseline, improvement
Other clinical outcomes
2 endpointsChange in Free Androgen Index
Time frame:Baseline and 12 weeks
Androgen, change
change from baseline, improvement
Change in Free Androgen Index
Time frame:Baseline and 12 weeks
Androgen, change
change from baseline, improvement
Posted result
| Group | Value (mean), unitless | 95% CI |
|---|---|---|
| Diet Intervention | -3.05 | — |
| GLP-1 Intervention | -2.45 | — |
Other (unclassified)
2 endpointsChange in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose
Time frame:Baseline and 12 weeks
percent change from baseline, improvement
Change in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose
Time frame:Baseline and 12 weeks
change from baseline, descriptive
Posted result
| Group | Value (mean), percentage of indirect glycerol carbon c | 95% CI |
|---|---|---|
| Diet Intervention | -1.59 | — |
| GLP-1 Intervention | 3.08 | — |
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Pediatric obesity2026 Apr (month)PMID42014131doi:10.1111/ijpo.70108via clinicaltrials gov reference derived + pubmed nct search
- Journal of the Endocrine Society2024 May 23PMID38895640doi:10.1210/jendso/bvae110via pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.