Liraglutide [amount hidden] (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS

What Was Tested

This registered phase 3 trial tested Liraglutide for pcos.

It had two arms (groups): Liraglutide Pen Injector (Saxenda) (experimental) and Placebo liraglutide pen injector (placebo 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.

All patients will receive diet and lifestyle counseling, including advice on exercise commencing during the lead-in period and continuing throughout the study.

Who Took Part

88 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: 18-45 years of age. BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more obesity-associated co-morbid conditions (e.g. hypertension, and dyslipidemia). PCOS- NIH criteria hyperandrogenism and irregular menstrual cyclicity. An intrauterine device, tubal sterilization, or male partner vasectomy, or. Combination of two barrier methods with one being male condom.

The full record lists 9 inclusion and 20 exclusion criteria; among the exclusions: untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm hg); prior history of a malignant disease requiring chemotherapy; family or personal history of familial medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The pcos 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.

Blinding on both sides kept the pcos participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-09-26 with completion listed for 2021-02-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Body Weight (BW) (time frame: 32 weeks of treatment). Free Androgen Index (FAI) (time frame: 32 weeks of treatment).

It also tracked 27 secondary outcomes, for example Body Mass Index (BMI), Change in Percent Body Weight, Abdominal Adiposity (Waist Circumference [WC], Waist-to-Hip Ratio, Waist-to Height Ratio [WHtR]) and Total Fat Mass Evaluated by DEXA.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 88 people with pcos.

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

More context: the Liraglutide compound page, PCOS research.