Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)

What Was Tested

This registered phase 4 trial tested Dulaglutide.

GLP-1 analogues represent new treatments in diabetes that cause weight loss.

Their effect on NASH in humans is unknown.

It had two arms (groups): one (experimental) and reinforced dietary monitoring (sham comparator).

Reinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations.

The registry classes the interventions as drug and other.

More on the Plan

The study will be conducted over the course of 80 weeks in 3 periods (13 visits): * Period I: Run-in phase of 4 weeks * Period II: Treatment phase of 52 weeks * Period III: Follow-up phase of 24 weeks.

The patient must return to the study centre to assess whether the response to treatment is time-dependent.

Who Took Part

The registry lists 93 planned participants were the target.

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: Age \> 18 years, \< 75 years. 25 \<BMI \<40 kg/m2. Person volunteered to participate in the study, informed about study organization and having signed the consent form. Person undergone the medical examination adapted to research.

The full record lists 10 inclusion and 25 exclusion criteria; among the exclusions: patients receiving rapid or short-acting mealtime insulin or premixed insulin in the last 6 months before screening visit; type 1 diabetes; patients with idiopathic hemochromatosis.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Dulaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2019-09-01 with completion listed for 2023-09-30.

It ran at 9 sites in France (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone) (time frame: after 52 weeks of treatment).

It also tracked 12 secondary outcomes, for example Fibrosis Kleiner score, Fibrosis using Fibrotest score, Fibrosis marker parameter, Changes in serum levels of liver enzymes ALT and AST, Changes in Lipid parameters and Change in body composition assessed by dual-energy x-ray absorptiometry scans.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 93 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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