A Pathophysiological Study of the Postprandial Human Liver (PLS)

What Was Tested

This registered not phased trial tested Glucagon for fatty liver & elevated liver enzymes.

Fatty liver disease is a globally widespread disease.

The identification of valid biomarkers and targets for potential treatments requires in-depth knowledge about the pathophysiology of the postprandial liver.

The study will consist of seven work packages (WP) including blood tests and liver biopsies taken after fasting or ingestion of a standardized meal in: healthy controls (WP 1), patients with NAFLD (WP 2), and patients with cirrhosis (WP 3) ; before and after a standardised meal in healthy controls (WP 4), and before and after glucagon in healthy controls (WP5), patients with NAFLD (WP6), and patients with T2DM and NAFLD (WP7).

It had three arms (groups): Blood tests and liver biopsies after fasting or ingestion of a standardized meal (experimental), Blood tests and liver biopsies before and after a standardized meal (experimental) and Blood tests and liver biopsies before and after a bolus of glucagon (experimental).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

87 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Glucagon group and the comparison group ran side by side rather than switching.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-03-02 with completion listed for 2025-08-21.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Postprandial phosphoproteomic changes in liver tissue in healthy individuals (time frame: 60 minutes after the meal administered at the study day).

It also tracked 7 secondary outcomes, for example Postprandial phosphoproteomic changes in liver tissue between healthy participants and patients with cirrhosis or patients with NAFLD, Postprandial phosphoproteomics, proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals and Postprandial proteomic, metabolomic and Peptidomic changes in blood obtained from liver vein and peripheral vein in healthy individuals.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glucagon in 87 people with fatty liver & elevated liver enzymes.

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

More context: the Glucagon compound page, Fatty liver & elevated liver enzymes research.