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RECRUITING Phase 3

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

NCT05819853 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Semaglutide Injectable Product (Wegovy and/or Ozempic)

Study Locations (1)

Colorado

  • University of Colorado Anschutz/Children's Hospital Colorado Aurora — Aurora

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2023-11-03
Est. Completion 2028-06-30
Phase Phase 3

Sponsor

University of Colorado, Denver

1,447 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05819853

The ClinicalTrials.gov registry entry for NCT05819853 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Obese appearing as the primary indexed condition, and to 1 intervention — of which Semaglutide Injectable Product (Wegovy and/or Ozempic) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05819853 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05819853 about?

NCT05819853 is a clinical study titled "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.

What is the current status of trial NCT05819853?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2023-11-03. Estimated completion is 2028-06-30.

What conditions does trial NCT05819853 study?

This clinical trial studies the following conditions: Obese, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05819853?

The interventions under investigation include: Semaglutide Injectable Product (Wegovy and/or Ozempic) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05819853?

This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05819853 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial