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PCOSPhase 2/3TEALNCT03919929

Treating PCOS With Semaglutide vs Active Lifestyle Intervention

A Phase 2/3 study testing Semaglutide 3mg and 7mg [Rybelsus] and Weight loss diet in people with PCOS and Adolescent Obesity, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 21 years, women only
Conditions the study is for
PCOS, Adolescent Obesity, NAFLD
What is being tested?
Semaglutide 3mg and 7mg [Rybelsus] and Weight loss diet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
3 May 2019to 3 Oct 2023
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 <84 lbs.
Show all 19Show fewer
  • Anemia, defined as Hemoglobin < 11 mg/dL
  • Diagnosed major psychiatric or developmental disorder limiting informed consent.
  • Implanted metal devices that are not compatible with MRI
  • Use of blood pressure medications.
  • Known liver disease other than NAFLD or AST or ALT >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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anshutz Medical Campus/Children's Hospital Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the detailed description

In obese girls with polycystic ovarian syndrome, testosterone and obesity combine to create unique pathology to increase metabolic disease including fatty liver and insulin resistance, which may be mediated by altered glucagon like peptide-1 activity. The investigators will treat girls with obesity and polycystic ovarian syndrome for 4 months with a glucagon like peptide-1 receptor agonist compared to dietary intervention to primarily lower hepatic fat and secondarily improve whole body and adipose insulin sensitivity. Mechanisms of hepatic metabolism, including rates of de novo lipogenesis and relative mitochondrial flux will also be assessed.

Being tested
Semaglutide 3mg and 7mg [Rybelsus], Weight loss diet
Keywords
Insulin Resistance
Medical subject headings
Pediatric Obesity, Non-alcoholic Fatty Liver Disease, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide 3mg and 7mg [Rybelsus]Drug

    Also called GLP-1 receptor agonist

    Once daily oral tablet of semaglutide for 4 months

  • Weight loss dietOther

    Prescribed weight loss diet to match weight loss in Drug arm

Study groups in NCT03919929
Study groupRoleWhat they receive
Diet InterventionActive comparatorWeight loss with dietary intervention
Receives: Other: Weight loss diet
GLP-1 InterventionExperimentalParticipants will take a daily oral tablet of semaglutide for 4 months.
Receives: Drug: Semaglutide 3mg and 7mg [Rybelsus]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hepatic Fat Fraction

    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.

    Measured: Baseline and 12 weeks

  2. Change in Weight

    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.

    Measured: Baseline and 12 weeks

Secondary outcomes (3)

  1. Change in Rate of De Novo Lipogenesis (DNL)

    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.

    Measured: Baseline and 12 weeks

  2. Change in Whole Body Insulin Sensitivity

    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.

    Measured: Baseline and 12 weeks

  3. Change in Adipose Insulin Sensitivity

    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.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start3 May 2019
  3. Primary completion3 Oct 2023
  4. Study completion3 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03919929
Sponsor's protocol ID
19-0636
Other IDs
1R01DK120612-01A1
Acronym
TEAL
Status last verified
Nov 2025
First submitted
15 Apr 2019
Last updated
25 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boster 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.

    PubMed 42014131

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Semaglutide 3mg and 7mg [Rybelsus] and Weight loss diet in people with PCOS and Adolescent Obesity, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hepatic Fat Fraction (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03919929, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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