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

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide for pcos.

It had two arms (groups): Untreated PCOS (experimental) and PCOS on Metformin (experimental).

The registry classes the interventions as drug.

More on the Plan

Polycystic ovary syndrome is one of the most common endocrinopathies in women, presents with anovulation in adolescence, and reproductive dysfunction is related to excess weight.

The researchers will assess the relationship between weight loss and reproductive function, as well as identify if age, hormonal and metabolic measures and such insulin sensitivity and insulin secretion predict the response to glucagon-like peptide-1 receptor agonist therapy.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to women only aged from 12 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ages 12-35 years. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week. 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.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: weight loss medications in the last 6 months; severe illness requiring hospitalization within 60 days.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2023-11-03 with completion listed for 2028-02-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in ovulation frequency before and after semaglutide in females with PCOS (time frame: 14 months).

It also tracked 2 secondary outcomes, for example Change in Whole Body Insulin Sensitivity and Change in ovarian morphology.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Semaglutide in 80 people with pcos.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, PCOS research.