A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 52 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) equal to or above 27.0 kg/m\^2. Stable body weight (less than 3 kg self-reported change during the previous 3 months). Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps); any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-03-16 with completion listed for 2017-02-27.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maximum postprandial gallbladder ejection fraction (GBEFmax) (time frame: At 12 weeks (visit 9)).

It also tracked 9 secondary outcomes, for example Gallbladder volume, Gallbladder volume, Area under gallbladder EF-time (ejection fraction) curve, Area under gallbladder EF-time curve, Area under the paracetamol concentration-time curve and Area under the paracetamol concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 52 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.