Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
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.
• 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:
‣ If \<18 years, initial BMI percentile ≥95
⁃ 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
⁃ Must be weight stable within ±5kg in the 3 months prior to enrollment
• Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia
• 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.
• For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening