L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Teduglutide (GLP-2 analog).

The gut is able to retain some fat for many hours after a fatty meal.

The gut hormone glucagon-like peptide-2 (GLP-2) is known to release these fat stores in the gut, but it is not known how GLP-2 achieves this.

It had three arms (groups): Teduglutide + Normal Saline (placebo comparator), Teduglutide + L-NMMA (active comparator) and Placebo + L-NMMA (placebo comparator).

Teguglutide + (L-NMMA control).

Tedulgutide + L-NMMA.

(Teduglutide control) + L-NMMA.

The registry classes the interventions as drug.

More on the Plan

This is a single-blind, cross over, Phase 3b clinical study.

Lipid and lipoprotein levels will be measured at regular intervals for 3 hours following the injection of Teduglutide.

Mesenteric blood flow will be measured at regular intervals by ultrasonography on some volunteers.

Study B (Teduglutide + normal saline): The design is identical to study A, except that, instead of L-NMMA, normal saline of the same volume will be infused.

Who Took Part

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 kg/m2 to 30 kg/m2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: subject has a history of hepatitis/hepatic disease that has been active within the previous two years; history of diabetes or oral glucose tolerance indicative of diabetes or impaired glucose tolerance; any laboratory values: aspartate transaminase \> 2x upper limit of normal; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 miliunit/l.

How the Study Was Run

The set-up was 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 2017-09-27 with completion listed for 2019-03-20.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Plasma Lipid Levels (time frame: 10.5 hours).

It also tracked 1 secondary outcome, for example Blood Flow.

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.