RecruitingPCOS (Polycystic Ovary Syndrome) of Bilateral OvariesObese
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Eligible age
12–35 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ 1. Female
- ✓ 2. Ages 12-35 years
- ✓ 3. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.
- ✓ 4. Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines
- ✓ 5. Initial BMI based on age and weight:
- ✓ 1. If \<18 years, initial BMI percentile ≥95
- ✓ 2. If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia
- ✓ 3. Must be weight stable within ±5kg in the 3 months prior to enrollment
You may not qualify if…
- ✕ 1. 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
- ✕ 2. 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.
- ✕ 3. Weight loss medications in the last 6 months
- ✕ 4. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- ✕ 5. Severe illness requiring hospitalization within 60 days.
- ✕ 6. Diabetes, defined as Hemoglobin A1C ≥6.5%
- ✕ 7. Anemia, defined as Hemoglobin \< 12 mg/dL
- ✕ 8. Diagnosed major psychiatric or developmental disorder limiting informed consent.
Where it's recruiting
Colorado
Aurora
Source: ClinicalTrials.gov · NCT05819853 · last updated 2025-08-28