A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Europe.

The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.

It had six arms (groups): A (experimental), B (experimental), C (experimental), D (experimental) and E (experimental).

The registry classes the interventions as drug.

Who Took Part

49 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body Mass Index (BMI) between 30.0-40.0 kg/m2. Stable body weight (below 5 kg body weight change during past 3 month).

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: history of chronic pancreatitis or idiopathic acute pancreatitis; previous or scheduled (during the trial period) surgical treatment for obesity; diagnosed type 1 or type 2 diabetes.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 and investigator.

It started in 2009-09-16 with completion listed for 2011-06-08.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of [amount hidden] paracetamol.

It also tracked 1 secondary outcome, for example Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 49 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.