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Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

Plain-language guide to NCT06896981: phase 2, phase 3 randomized trial of Semaglutide, pcos, 31 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06896981
Phase
phase 2, phase 3
Status
completed
Start
2025-01-01
Completion (planned or actual)
2025-10-31
Participants
31 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Polycystic Ovary Syndrome (PCOS) Women; Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

The syndrome is typically characterized by reproductive and dermatological manifestations such as irregular menstrual cycles, subfertility, hirsutism, and acne.

These countries are densely populated and, like many regions of the world, also have people who suffer from PCOS.

Hence, obesity is now considered a secondary cause of PCOS (pseudo-PCOS).

Lifestyle is the cornerstone in the management of PCOS and obesity.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to women only aged from 10 years up to 45 years.

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

The full record lists 0 inclusion and 8 exclusion criteria; among the exclusions: patients having pcos mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, cushing's syndrome, acromegaly, hypothalamic disorder etc.); those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months; those who have undergone bariatric surgery.

How the Study Was Run

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

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

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-01-01 with completion listed for 2025-10-31.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight (time frame: 12 weeks). Body mass index (time frame: 12 weeks). Waist circumference (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Total testosterone, Sex hormone binding globulin, Free androgen index and Alanine amino transferase.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide in 31 people with pcos.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, PCOS research.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.