Actively Recruiting
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Led by University of Colorado, Denver · Updated on 2025-08-28
80
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Ages 12 to 35 years
- Less than 2 hours of moderate exercise per week
- Oligomenorrhea as defined by 2018 PCOS guidelines, on or off metformin
- For under 18 years, BMI percentile of 95 or higher
- For 18 to 35 years, BMI of 30 kg/m2 or higher, or BMI of 27 kg/m2 or higher with at least one weight-related condition such as hypertension or dyslipidemia
- Weight stable within plus or minus 5 kg in the 3 months before enrollment
- Diagnosed with PCOS using NIH criteria adapted for adolescents
- Not using hormonal contraception and willing to remain abstinent or use reliable non-hormonal contraception during the study
- For metformin plus semaglutide group, stable on at least 1500 mg metformin daily for 3 months before screening
You will not qualify if you...
- Diagnosis or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- Use of medications affecting insulin sensitivity including recent metformin use for untreated group, oral steroids, atypical antipsychotics, immunosuppressants, HIV medications, or hormonal contraception within specified times before screening
- Use of weight loss medications in the last 6 months
- Currently pregnant or breastfeeding
- Severe illness requiring hospitalization within 60 days
- Diabetes with Hemoglobin A1C of 6.5% or higher
- Anemia with Hemoglobin below 12 mg/dL
- Major psychiatric or developmental disorders limiting consent
- Known liver disease other than NAFLD or elevated liver enzymes above 125 IU/L
- Personal history of pancreatitis
- Known kidney disease or low kidney function (eGFR below 45 ml/min/1.73m2)
- Severe gastrointestinal disease such as gastroparesis
- History of gallstones
- Untreated thyroid disease
- Allergy or hypersensitivity to semaglutide
- Other causes of high androgen levels or amenorrhea not related to PCOS
- Active eating disorders or binging/purging behaviors
- Planning pregnancy within the next 12 to 18 months
- History of bariatric surgery
- Frequent use of THC (more than 3 days per week)
- Alcohol use exceeding 2 drinks more than 3 days per week
- Inability or unwillingness to commit to abstinence or use of specific non-hormonal contraception methods during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz/Children's Hospital Colorado Aurora
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
Y
Yesenia Garcia-Reyes, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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