The Effect of Liraglutide on the GIT

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Its mechanism of action has not yet been elucidated.

The researchers want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food intake in healthy volunteers.

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

The registry classes the interventions as drug.

More on the Plan

GLP-1 infusion in humans suppresses hunger-inducing MMC contractility.

Therefore, the researchers will recruit 15 healthy subjects which will participate to this double-blind, placebo-controlled crossover trial.

On the 4th day, the injection will be combined with a motility study (fasted state), and on the 5th day with an ad libitum buffet.

The amount and preference for certain types of food is tested during an ad libitum free choice buffet (only on 5th day of treatment arm).

Who Took Part

The registry lists 15 planned participants were the target.

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: Subject is female or male between 18 and 65 years of age. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: subject is under age of legal consent, pregnant or breastfeeding; subject with a bmi ≤ 18 kg/m² or bmi ≥ 25 kg/m²; subject has diabetes.

How the Study Was Run

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

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

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

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 2020-04-01 with completion listed for 2021-04-01.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: MMC activity compared between placebo and treatment with liraglutide.

It also tracked 4 secondary outcomes, for example Gastrointestinal hormone release compared between placebo and treatment with liraglutide, Hunger sensations compared between placebo and treatment with liraglutide, Ad libitum food intake compared between placebo and treatment with liraglutide and Glucose whole blood levels compared between placebo and treatment with liraglutide.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 15 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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