Treatment of Bile Acid Malabsorption With Liraglutide

What Was Tested

The trial (phase 4) is built around Liraglutide.

Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam.

It had two arms (groups): Liraglutide/placebo-colesevelam (active comparator) and Placebo-Liraglutide/colesevelam (active comparator).

Liraglutide as active and colesevelam as placebo.

Liraglutide as placebo and colesevelam as placebo.

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 aged from 18 years up to 75 years.

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

Examples of who could join: • Caucasian ethnicity. Age above 18 years and below 75 years. Informed and written consent. BMI \>18,5 kg/m2 and \<40 kg/m2.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: gastrointestinal disease (except for bam), previous intestinal resection or any major intra-abdomial surgery; diabetes mellitus; treatment with medicine that cannot be paused for 12 hours.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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.

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 2019-03-07 with completion listed for 2021-03-10.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in stool fequency (time frame: 7 weeks).

It also tracked 3 secondary outcomes, for example Total symptoms score, quality of life scores, and biomarker, Change in SeHCAT and Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea.

What This Means in Plain Language

Put simply, this is a phase 4, 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.