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
21 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
This research aims to study girls and women aged 12 to 35 years with obesity and polycystic ovary syndrome (PCOS), focusing on how a glucagon-like peptide-1 receptor agonist affects metabolic health, weight loss, and reproductive issues. The trial observes participants either on or off metformin to understand the link between weight loss and reproductive function, as well as how age and hormone and metabolic factors influence responses to treatment. Participants receive 10 months of semaglutide treatment, a medication given by injection, with doses gradually increased as recommended by the manufacturer up to a maximum of 1.7 mg. There are two groups: one includes participants not taking metformin or hormonal therapy, and the other includes participants currently on metformin who continue their usual dose while receiving semaglutide. The study starts with a 4-month observation period before treatment. Throughout the trial, participants undergo assessments of ovulation frequency, insulin sensitivity, and ovarian shape. These evaluations happen at the start and after 10 months of treatment, with ovulation change measured over 14 months. Researchers track metabolic and reproductive changes using clinical exams, blood tests, and imaging. The total study participation lasts over a year, including observation and treatment phases, with safety and treatment effects carefully monitored.
CONDITIONS
Brief 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
- Aged 12 to 35 years
- Sedentary lifestyle with less than 2 hours of moderate exercise weekly
- Oligomenorrhea consistent with PCOS diagnostic guidelines
- Initial BMI meeting age-specific criteria (percentile 65 for under 18, 630 kg/m2 or 627 kg/m2 with comorbidity for 18-35 years)
- Stable weight within �b15 kg in the 3 months before enrollment
- Diagnosed with PCOS by NIH criteria adapted for adolescents
- Not using hormonal contraception; willing to practice abstinence or non-hormonal contraception during the study
- For metformin group, stable dose of 61500 mg daily for at least 3 months prior to screening
You will not qualify if you...
- Personal or family history of medullary thyroid carcinoma or MEN2 syndrome
- Use of insulin sensitivity-affecting medications recently, including metformin in untreated group within 3 months
- Recent use of weight loss medications within 6 months
- Currently pregnant or breastfeeding
- Severe illness requiring hospitalization within last 60 days
- Diabetes with Hemoglobin A1C 65.5%
- Anemia with Hemoglobin less than 12 mg/dL
- Major psychiatric or developmental disorders affecting consent
- Known liver disease other than NAFLD or elevated liver enzymes
- History of pancreatitis or severe gastrointestinal disease
- Known kidney disease or low kidney function
- History of gallstones or untreated thyroid disease
- Allergic reaction to semaglutide
- Other causes of hyperandrogenism or amenorrhea
- Active eating disorders
- Planning pregnancy within 12-18 months
- Previous bariatric surgery
- Regular use of THC or alcohol beyond specified limits
- Inability or unwillingness to commit to required contraception methods during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants undergo a 4-month observation period without medication or with metformin treatment to assess baseline reproductive and metabolic status.
Visits scheduled per protocol during observation
Duration - 10 months
Participants receive 10 months of semaglutide with dose escalation to induce weight loss and improve reproductive function. Participants on metformin continue their medication during this period.
Regular visits for dose escalation and monitoring during 10 months
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
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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