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Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Plain-language guide to NCT05965908: phase 3 randomized trial of Liraglutide, 183 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05965908
Phase
phase 3
Status
completed
Start
2024-08-01
Completion (planned or actual)
2025-11-30
Participants
183 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Polycystic Ovary
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Liraglutide.

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

It had three arms (groups): liraglutide (experimental), metformin (active comparator) and control (no intervention).

Not given any drug.

The registry classes the interventions as drug.

More on the Plan

The trial will be included 150 women with Poly cystic ovary syndrome based on the Rotterdam criteria.

Who Took Part

Enrollment: 183 actual participants took part.

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: Women aged 18-45 years. Poly cystic ovary syndrome based on the Rotterdam criteria.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: congenital adrenal hyperplasia,; poorly controlled thyroid disease; taking antidiabetic drugs which can affect insulin resistance.

How the Study Was Run

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

Because people in this Liraglutide 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 participants stayed in one arm throughout.

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

It started in 2024-08-01 with completion listed for 2025-11-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Insulin Resistance (HOMA-IR) (time frame: 6-months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 183 people.

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

More context: the Liraglutide compound page, all human trials.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

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.