Primary outcomeMean· Baseline and 12 weeks
Change in Hepatic Fat Fraction
| Group | Value (Change in percentage of liver fat) | Spread |
|---|---|---|
| Diet Intervention | -1.41 | 2.24 |
| GLP-1 Intervention | -1.84 | 4.39 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataTreating PCOS With Semaglutide vs Active Lifestyle Intervention
Short name TEAL
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 60 participants (actual)
- Sponsor
- University of Colorado, Denver · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 3 May 2019
- Primary completion
- 3 Oct 2023
- Completion
- 3 Oct 2023
- First posted
- 18 Apr 2019
- Last update posted
- 25 Nov 2025
- Conditions
- PCOS · Adolescent Obesity · NAFLD
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021202220232024
- Ph 2/3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide 3mg and 7mg [Rybelsus]Drug
- Weight loss dietOther
Arms2
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 outcomes2
Outcomes the sponsor listed as primary.
Change in Hepatic Fat Fraction
Time frame · Baseline and 12 weeks
Registry description
Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%. A negative value means a decrease in liver fat, and a positive value means an increase in liver fat.
Change in Weight
Time frame · Baseline and 12 weeks
Registry description
Change in weight will be calculated for each group (diet and semaglutide), and both the absolute and relative weight changes between the two groups will be reported.
Secondary outcomes(3)
Change in Rate of De Novo Lipogenesis (DNL)
Time frame · Baseline and 12 weeks
Registry description
Change from baseline of the rate of overnight de novo lipogenesis (DNL) will be measured utilizing stable isotope methods with deuterated water, and expressed as the rate of newly synthesized lipids in the serum triglyceride fraction. A negative value means a decrease in newly synthesized lipids after the 12 week intervention, and a positive value means an increase in newly synthesized lipids after the 12 week intervention. A lower value is better.
Change in Whole Body Insulin Sensitivity
Time frame · Baseline and 12 weeks
Registry description
Participants will undergo a 75 gram oral glucose tolerance test, and the change from baseline in whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model.
Change in Adipose Insulin Sensitivity
Time frame · Baseline and 12 weeks
Registry description
Change from baseline of adipose insulin sensitivity will be calculated as the percent suppression of free fatty acids, and the nadir of free fatty acids during the oral glucose tolerance test. Percent suppression of FFAs during the OGTT was calculated as fasting FFA minus the minimal FFA value divided by fasting FFA. This was calculated for baseline and after 12-weeks of intervention. The change was calculated by subtracting the final-baseline values. A higher absolute value means there was an improvement in adipose insulin sensitivity after 12-weeks of treatment.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline and 12 weeks
Change in Weight
| Group | Value (Change in weight (KG)) | Spread |
|---|---|---|
| Diet Intervention | -1.66 | 2.81 |
| GLP-1 Intervention | -5.30 | 4.92 |
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline and 12 weeks
Change in Rate of De Novo Lipogenesis (DNL)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Diet Intervention | 0.94 | 5.7 |
| GLP-1 Intervention | -1.9 | 1.0 |
Secondary outcomeMean· Baseline and 12 weeks
Change in Whole Body Insulin Sensitivity
| Group | Value (dl/kg/min per microU/ml) | Spread |
|---|---|---|
| Diet Intervention | 0.0000629 | 0.000193 |
| GLP-1 Intervention | 0.000213 | 0.000423 |
Secondary outcomeMean· Baseline and 12 weeks
Change in Adipose Insulin Sensitivity
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Diet Intervention | 0.44 | 12.06 |
| GLP-1 Intervention | -1.431 | 9.97 |
Other pre specified outcomeMean· Baseline and 12 weeks
Change in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose
| Group | Value (percentage of indirect glycerol carbon c) | Spread |
|---|---|---|
| Diet Intervention | -1.59 | 3.19 |
| GLP-1 Intervention | 3.08 | 5.24 |
Other pre specified outcomeMean· Baseline and 12 weeks
Change in Free Androgen Index
| Group | Value (unitless) | Spread |
|---|---|---|
| Diet Intervention | -3.05 | 4.94 |
| GLP-1 Intervention | -2.45 | 3.27 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Diet InterventionWeight loss with dietary intervention Weight loss diet: Prescribed weight loss diet to match weight loss in Drug arm | 0 / 17 | 0 / 17 | 0 / 17 |
| GLP-1 InterventionParticipants will take a daily oral tablet of semaglutide for 4 months. Semaglutide 3mg and 7mg \[Rybelsus\]: Once daily oral tablet of semaglutide for 4 months | 0 / 38 | 0 / 38 | 0 / 38 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedBoster JM, Cree MG, Kelsey MM, Nadeau KJ, Chaidez A, Pan Z, Sundaram SS. Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity. Pediatr Obes. 2026 Apr;21(4):e70108. doi: 10.1111/ijpo.70108. PMID 42014131
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 12 Years up to 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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