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Weight-Loss drug semaglutide takes on PCOS in teen girls

NCT ID NCT03919929

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested whether the diabetes drug semaglutide (Rybelsus) could help 60 adolescent girls with PCOS and obesity reduce liver fat and improve insulin sensitivity, compared to a weight loss diet. Participants took a daily oral tablet for 4 months or followed a prescribed diet. The goal was to see if the drug could better manage metabolic syndrome linked to PCOS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide (Rybelsus)
What this could lead to
If it works, this could point toward a medication option for managing PCOS-related metabolic issues in teens without lifelong hormone therapy.
What could go wrong
This is a small, early-phase study with only 60 participants, so results may not apply broadly. Semaglutide can cause nausea and other side effects, and the diet group may not achieve similar weight loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

60 people

The number who actually took part.

Started

May 2019

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 21 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Aurora, Colorado, 80045, United States

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