GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations

What Was Tested

The trial (phase 2) is built around Liraglutide.

The obesity epidemic is attributable to dietary and behavioral trends acting on a person's genetic makeup to determine body mass and susceptibility to obesity-related diseases.

Furthermore, common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated insulin secretion.

It had two arms (groups): Control Group (experimental) and Case Group (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI above 28 (kg/m2). Age 18-65 years.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: pregnancy or breastfeeding; type 2 diabetes; suffering from severe medical conditions.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2014-06 with completion listed for 2016-04.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls (time frame: 4 months intervention).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Liraglutide in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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