Effect of Liraglutide on Microbiome in Obesity

What Was Tested

This registered phase 4 trial tested Liraglutide for fat loss, obesity & body recomposition.

It had two arms (groups): Active drug (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In this trial approximately 70 subjects will be randomly assigned to trial product.

Who Took Part

70 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial;. Age ≥ 18 years and \< 65 years at the time of signing informed consent;. Body mass index (BMI) ≥ 30 kg/m2. Stable body weight during the previous 3 months (\< 5 kg self-reported weight change).

The full record lists 4 inclusion and 28 exclusion criteria; among the exclusions: current use or use within three months before this trial of glp-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine;; type 1 diabetes;; type 2 diabetes;.

How the Study Was Run

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

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.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Liraglutide.

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

It started in 2019-01-09 with completion listed for 2020-01-09.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in gut microbiome composition assessed by Firmicutes-to-Bacteroidetes ratio using Quantitative polymerase chain reaction (PCR) (time frame: Change from baseline in gut microbiome composition at weeks 5 (visit 7)).

It also tracked 20 secondary outcomes, for example Change in body weight (kg) assessed by scale, Change in body composition assessed by Bioelectrical impedance analysis (BIA), Change in hormonal regulation of appetite assessed by ghrelin levels, Change in hormonal regulation of hunger suppression assessed by cholecystokinin levels, Change in hormonal regulation of appetite assessed by polipeptide YY levels and Change in hormonal regulation of weight assessed by leptin levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 70 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.