Plasma Lipoprotein Response to Glucagon-like Peptide-2

What Was Tested

The trial (phase 2, phase 3) is built around Teduglutide (GLP-2 analog).

Some of the fat (triglyceride) from the food humans eat gets stored in the bowel.

This triglyceride can then be released into the blood when another meal is consumed or in response to hormones.

How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known.

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

The registry classes the interventions as drug.

More on the Plan

Each subject will be their own control, receiving both placebo and teduglutide, administered on separate occasions.

A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur on visit 2.

On visit 3 \& 4 participants will receive a high fat liquid meal after an overnight fast.

Hourly blood samples will be taken for 5 hours, followed by randomized assignment to receive either subcutaneous placebo or teduglutide at visit 3 and the opposite treatment at visit 4.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women, aged 18 to 60 years. Body mass index 20 to 27 kg/m2.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: patients with active inflammatory bowel disease; patients with pre-existing celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption; patients with active bowel malignancy.

How the Study Was Run

Design: randomized, crossover and single-blind.

Because people in this Teduglutide (GLP-2 analog) 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 Teduglutide (GLP-2 analog) and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Teduglutide (GLP-2 analog) was given.

Those kept unaware of assignments: participant.

It started in 2018-09-21 with completion listed for 2021-06-01.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Lipoprotein response to teduglutide (time frame: 8 hours).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Teduglutide (GLP-2 analog) in 10 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.