A study testing whether a GLP-1 medicine from University of Colorado, Denver, semaglutide, can help with PCOS.
What this means for you
- Who can join
- Ages 12 to 35, women only, have polycystic ovary syndrome (PCOS), BMI 27+.
- What you take
- semaglutide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 4.6 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. Also studied in: Obese.
Full scientific study title: Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome.
Who can join
Ages 12 to 35, women only, have polycystic ovary syndrome (PCOS), BMI 27+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- Female
- Ages 12-35 years
- Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
- Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
- Initial BMI based on age and weight:
Key exclusion criteria
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label
- Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 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.
- Weight loss medications in the last 6 months
- 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.
Where this study is enrolling
This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.
Colorado1 site
- University of Colorado Anschutz/Children's Hospital Colorado AuroraAurora, Colorado
Timeline
Started enrolling: 2023-11-03. Expected completion: 2028-06-30. Last updated on ClinicalTrials.gov: 2025-08-28.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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