Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing Semaglutide Injectable Product (Wegovy and/or Ozempic) for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
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.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Semaglutide Injectable Product (Wegovy and/or Ozempic). The registry lists allocation as randomized. 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.
They plan to enroll about 80 people at Aurora. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
Primary outcome (registry wording): Change in ovulation frequency before and after semaglutide in females with PCOS
Who it is for (from inclusion criteria)
Ages 12 Years to 35 Years
Women only
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 body-mass index (BMI) based on age and weight:
If \<18 years, initial body-mass index (BMI) percentile ≥95
If 18-35 years, initial body-mass index (BMI) ≥30 kg/m2 OR initial body-mass index (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
Who the registry excludes
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
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
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05819853?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05819853?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.