← Trials/Trial dossier/NCT03919929

TEAL

CompletedPhase 2, PHASE3Results posted

Treating PCOS With Semaglutide vs Active Lifestyle Intervention

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, changeBody 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

NCT IDNCT03919929
Org study ID19-0636
Secondary ID1R01DK120612-01A1

Timeline

Milestones

Study first posted2019-04-18actual
Study start2019-05-03actual
Primary completion2023-10-03actual
Study completion2023-10-03actual
Last update posted2025-11-25actual
Results first posted2025-11-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age12 Years
Maximum age21 Years
SexFemale
Healthy volunteersNot accepted

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

Glycemic / diabetes
4
MASH / liver
3
Weight & body composition
2
Other clinical outcomes
2
Other (unclassified)
2
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Primary/registry result

Change in Weight

Time frame:Baseline and 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Change in weight (KG)95% CI
Diet Intervention-1.66
GLP-1 Intervention-5.30
Primary/protocol endpoint

Change in Weight

Time frame:Baseline and 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/registry result

Change in Whole Body Insulin Sensitivity

Time frame:Baseline and 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), dl/kg/min per microU/ml95% CI
Diet Intervention0.0000629
GLP-1 Intervention0.000213
Secondary/registry result

Change in Adipose Insulin Sensitivity

Time frame:Baseline and 12 weeks

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage of change95% CI
Diet Intervention0.44
GLP-1 Intervention-1.431
Secondary/protocol endpoint

Change in Whole Body Insulin Sensitivity

Time frame:Baseline and 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in Adipose Insulin Sensitivity

Time frame:Baseline and 12 weeks

change from baseline, improvement

MASH / liver

3 endpoints
Primary/registry result

Change in Hepatic Fat Fraction

Time frame:Baseline and 12 weeks

Liver fat content, change

change from baseline, improvement

Posted result

GroupValue (mean), Change in percentage of liver fat95% CI
Diet Intervention-1.41
GLP-1 Intervention-1.84
Primary/protocol endpoint

Change in Hepatic Fat Fraction

Time frame:Baseline and 12 weeks

Liver fat content, change

change from baseline, improvement

Secondary/registry result/low confidence

Change in Rate of De Novo Lipogenesis (DNL)

Time frame:Baseline and 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Diet Intervention0.94
GLP-1 Intervention-1.9

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in Rate of De Novo Lipogenesis (DNL)

Time frame:Baseline and 12 weeks

change from baseline, improvement

Other clinical outcomes

2 endpoints
Other/protocol endpoint

Change in Free Androgen Index

Time frame:Baseline and 12 weeks

Androgen, change

change from baseline, improvement

Other_pre_specified/registry result

Change in Free Androgen Index

Time frame:Baseline and 12 weeks

Androgen, change

change from baseline, improvement

Posted result

GroupValue (mean), unitless95% CI
Diet Intervention-3.05
GLP-1 Intervention-2.45

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Change in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose

Time frame:Baseline and 12 weeks

percent change from baseline, improvement

Other_pre_specified/registry result/low confidence

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

GroupValue (mean), percentage of indirect glycerol carbon c95% CI
Diet Intervention-1.59
GLP-1 Intervention3.08

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.