Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

What Was Tested

This registered phase 4 trial tested Liraglutide.

The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.

It had 1 arm (groups): Liraglutide Group (experimental).

Participants in this group will receive the Liraglutide intervention for 12 months.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: BMI ≥27 kg/m2. At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes \[IFG, IGT\], hypertension, dyslipidemia). Age \> 18 and \< 70 years old.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: type 1 diabetes, as defined by american diabetes association (ada) criteria; insulin dependent or treated type 2 diabetes; current use of other injectable incretins.

How the Study Was Run

The set-up was single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-09-01 with completion listed for 2021-09-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Epicardial Fat Thickness (time frame: Baseline, 12 months).

It also tracked 2 secondary outcomes, for example Change in serum immunoglobulins and Change in plasma ceramide levels.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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