Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

What Was Tested

In this phase 4 trial, researchers set out to test Dulaglutide for fatty liver & elevated liver enzymes.

It had three arms (groups): Empagliflozin (experimental), Dulaglutide (experimental) and Empagliflozin and Dulagludie (experimental).

The registry classes the interventions as drug.

Who Took Part

135 planned participants were the target.

It was open to people of any sex aged from 20 years up to 90 years.

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

Examples of who could join: Age 20 or over. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m). MAFLD: presence of any conditions. Overweight or obese: BMI ≥23 kg/m2 (Asian). Metabolic dysregulation: at least of two of following criteria.

The full record lists 13 inclusion and 9 exclusion criteria; among the exclusions: other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, wilson's disease, alpha1 anti-trypsin deficiency, celiac disease, overt hypothyroidism, other secondary causes; type 1 diabetes mellitus; medication usage within 3 months: vitamin e, pufa, udca, fish oil, sglt2 inhibitors, glp1-ras, tzds.

How the Study Was Run

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

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2023-12-01 with completion listed for 2024-06-30.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes of HbA1c level (time frame: baseline, week 12, week 24). Changes of CAP score (time frame: baseline, week 24).

It also tracked 9 secondary outcomes, for example Changes of LSM score, Changes of noninvasive liver fibrosis markers, Changes of body weight and body composition, Changes of lipid levels, Changes of ketone levels and Changes of liver parenchyma by ultrasonography.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 135 people with fatty liver & elevated liver enzymes.

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

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