Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

Plain-language guide to NCT02721888: phase 4 interventional trial of Liraglutide, fatty liver & elevated liver enzymes, 127 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02721888
Phase: phase 4
Status: terminated early
Start: 2012-07-10
Completion (planned or actual): 2019-10-02
Participants: 127 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Liraglutide for fatty liver & elevated liver enzymes.

It had 1 arm (groups): Main study (experimental).

The registry classes the interventions as biological, drug and other.

Who Took Part

127 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with type 2 diabetes. Patients treated by metformin and/or sulfonylureas (or glinides) and/or acarbose and/or insulin,. Patients who gave their written consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: treatment with thiazolidinediones or other glucagon-like peptide-1(glp1) agonist; no treatment with a dipeptidyl peptidase-4 (dpp4) inhibitor during the 3 previous months,; renal or hepatic failure,.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-07-10 with completion listed for 2019-10-02.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of liraglutide on fatty liver content evaluated by proton-spectroscopy (1H-spectroscopy and lipoprotein kinetics, in patients with type 2 diabetes. Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein B (apoB) production rate. Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein B (apoB) production rate.

It also tracked 3 secondary outcomes, for example Modification of body weight, Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI) and Modification of visceral fat by Magnetic Resonance Imaging (MRI).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 127 people with fatty liver & elevated liver enzymes.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.