Weight-Loss drug semaglutide takes on PCOS in teen girls
NCT ID NCT03919929
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
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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
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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 Hide 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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