Efficacy of Liraglutide Therapy in Patients With IPAA

What Was Tested

This registered phase 2 trial tested Liraglutide.

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

Participants will be randomly assigned to 6-week Liraglutide treatment. Then after a 5-day washout, treatment will continue with 6 weeks of placebo.

Participants will be randomly assigned to 6-week placebo treatment. Then after a 5-day washout, treatment will continue with 6 weeks of Liraglutide.

The registry classes the interventions as drug.

More on the Plan

Randomized, double-blind, 2-period, placebo- controlled, crossover proof of concept study.

Subjects will be randomized 1:1 to 1 of 2 treatment sequences, liraglutide-placebo or placebo-liraglutide, and receive either liraglutide or volume-matched placebo.

After a wash-out period of at least 5 days (the half-life of liraglutide is 11-12 hours, thus the minimal washout period of 5 days is equal to 10 half-life's) patients will be crossed over to the other treatment arm (Period 2).

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent will be obtained before any trial-related procedures. Age \> 18 years.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: known stricture of the ileo-anal anastomosis or afferent limb stricture; new onset of high bowel frequency in the setting of acute pouchitis; IPAA since \< 6 months.

How the Study Was Run

It was run as a randomized, crossover and quadruple-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.

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, care provider, investigator and outcomes assessor.

It started in 2022-03-22 with completion listed for 2023-10-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in the 7 Day Mean Number of Day and Night Bowel Frequency at Week 4 and 6 vs Baseline on Liraglutide vs Placebo and Discontinuation of Therapy in Each Treatment Arm.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 8 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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