Liraglutide Effects on Memory in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Liraglutide.

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

See "Intervention".

See "Intervention".

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

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

Examples of who could join: Age 18-35 years. Body mass index between 19 and 25 kg/m2.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: receipt of any drug within 4 weeks prior to this trial; any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease; brady- and tachycardia, i.e. heart rate \< 50 and \> 90 beats per minute.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2012-05 with completion listed for 2013-12.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in the immediate and delayed recall of a declarative memory task (word list recall) at time points indicated in "time frame" section. Change from baseline in the immediate and delayed recall of an Episodic Memory Task (story recall) at the time points indicated in the "Time Frame" - section (time frame: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)). Change from baseline in performance on a two-dimensional object location task on day 1 and day 35 (time frame: Day -7, Day 1, Day 35).

It also tracked 2 secondary outcomes, for example Change from baseline in resting metabolic rate on day 7, 28 and 35 and Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 40 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.