Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)

What Was Tested

This registered phase 2, phase 3 trial tested Semaglutide for pcos.

The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period.

The main question it aims to answer is: • Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS?

Participants will be divided into 2 groups by chance.

It had two arms (groups): Metformin (active comparator) and Semaglutide (active comparator).

Participants in this group will be given metformin.

Participants in this group with receive Semaglutide.

The registry classes the interventions as drug.

More on the Plan

However, the effect of metformin on body weight (a major contributor of pathophysiology and symptoms in PCOS) remained highly variable between these patients.

The first observational study of metformin in PCOS reported weight loss during metformin therapy.

Liraglutide is administered as a daily subcutaneous injection whereas Semaglutide is administered as a weekly subcutaneous injection.

This is a randomized controlled trial The trial consists of 7 visits and 3 telephone calls.

Who Took Part

60 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Willingness and ability to provide signed informed consent prior to any trial activity. Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria \[12\]. Body mass index ≥30 kg/m2. Negative pregnancy test during screening visit and agree to use barrier contraception during the study period. Participants from all ethnicities who are English speakers.

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: non-classical 21-hydroxylase deficiency, hyperprolactinaemia, cushing's disease, and androgen-secreting tumours will be excluded by appropriate tests; confirmed type 2 diabetes and type 1 diabetes; pregnancy, breastfeeding or intends to become pregnant.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Semaglutide study: the pcos participants and staff both knew the treatment.

It started in 2025-03-01 with completion listed for 2025-09-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight loss (kg) (time frame: 28 weeks).

It also tracked 5 secondary outcomes, for example Fat mass, Free androgen index (FAI), Blood pressure, Pulse rate and Glucose tolerance.

What This Means in Plain Language

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, PCOS research.