Treating PCOS With Semaglutide vs Active Lifestyle Intervention

What Was Tested

The trial (phase 2, phase 3) is built around Semaglutide for pcos.

It had two arms (groups): Diet Intervention (active comparator) and GLP-1 Intervention (experimental).

Weight loss with dietary intervention.

Participants will take a daily oral tablet of semaglutide for 4 months.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 60 actual participants took part.

It was open to women only aged from 12 years up to 21 years.

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

Examples of who could join: Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week. BMI equal or greater than the 90th percentile for age and gender. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses \>12 months post-menarche and clinical or biochemical hypertestosteronemia.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: 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; BMI percentile less than the 90th percentile for age and sex. Weight \>325 lbs. or \<84 lbs.

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

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

It started in 2019-05-03 with completion listed for 2023-10-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Hepatic Fat Fraction (time frame: Baseline and 12 weeks). Change in Weight (time frame: Baseline and 12 weeks).

It also tracked 3 secondary outcomes, for example Change in Whole Body Insulin Sensitivity and Change in Adipose Insulin Sensitivity.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide in 60 people with pcos.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, PCOS research.