Liraglutide Effects on Epicardial Fat Inflammatory Genes

What Was Tested

This registered phase 4 trial tested Liraglutide.

Epicardial adipose tissue (EAT) is the visceral fat of the heart.

EAT could locally affect the coronary arteries through local secretion of pro-inflammatory cytokines.

EAT plays a role in the development of the coronary artery disease (CAD).

It had two arms (groups): L-group (active comparator) and D-group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 38 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: T2DM as defined by American Diabetes Association (ADA) criteria. Age ≥ 18 years old. Body mass index (BMI) ≥ 27 Kg/m2 and/or waist circumference ≥ 102 cm (40 inches) in men and 88 cm (35 inches) in women, respectively.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: patients with a personal or family history of medullary thyroid carcinoma or patients with multiple endocrine neoplasia syndrome type 2; patients with a prior serious hypersensitivity reaction to liraglutide; other contra-indications to liraglutide in accordance with risks and safety information included in the latest updated prescribing information.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2018-09-01 with completion listed for 2024-09-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): EAT Inflammation (time frame: Up to 12 weeks).

It also tracked 3 secondary outcomes, for example EAT Thickness, SAT Inflammation and Epicardial Adipose Tissue Glucagon Like 1 Receptor (EAT-GLP-1R).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 38 people.

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

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

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