Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility

What Was Tested

This registered phase 3 trial tested Liraglutide for fat loss, obesity & body recomposition and pcos.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and one of the leading causes of infertility.

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

The registry classes the interventions as drug.

More on the Plan

Liraglutide is an acylated human glucagon-like peptide -1 (GLP-1) analog that binds to and activates the GLP-1 receptor.

For obesity management, patients may lose weight with GLP-1 receptor agonists due to other unique actions.

While predictors of weight loss success for the general population are available (protein intake, weight loss medications), predictors of weight loss success may differ between normal and hyperandrogenic women.

Who Took Part

188 planned participants were the target.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: 18-65 years of age. Diagnosis of polycystic ovary syndrome according to the revised Rotterdam criteria (2003). BMI ≥ 27 kg/m2. Agree to participate in the study.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: type 1 or type 2 diabetes; history of acute or chronic pancreatitis; family or individual history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

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

It started in 2023-11-01 with completion listed for 2025-12-31.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Body Weight (BW) (time frame: 12 weeks of treatment). Change in Percent Body Weight (time frame: 12 weeks of treatment).

It also tracked 58 secondary outcomes, for example Body Mass Index (BMI), Abdominal Adiposity (Waist Circumference [WC]), Waist-to-Hip Ratio (WHR), Waist-to Height Ratio [WHtR], Total Fat Mass Evaluated by BIA and Total Body Fat (%) by BIA (Bioelectrical Impedance Analysis) machine.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 188 people with fat loss, obesity & body recomposition.

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

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research, PCOS research.