Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04642261 |
Other study ID # |
UW 20-065 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
December 2023 |
Source |
The University of Hong Kong |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25%.
Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are
associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2)
inhibitors can reduce hepatic fat content in patients with DM. However, the role of SGLT2
inhibitors in NAFLD patients without DM has not been investigated. Magnetic resonance
imaging-derived proton density fat fraction (MRI-PDFF) and liver stiffness measurement (LSM)
are non-invasive methods to diagnose hepatic steatosis and fibrosis/cirrhosis, respectively.
The investigators propose a double-blind, randomized, placebo-controlled trial to compare the
effects of empagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in
reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients without DM. A total of
98 adult patients will be randomly sampled from the liver clinic in our local hospital.
Empagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be
manufactured to be identical in appearance to the study drug. Eligible subjects will be
followed up until week 52, and will undergo clinical, anthropometric and laboratory
assessments (including liver function test and fasting blood) at baseline, week 6, 12, 26, 40
and 52. They will undergo LSM at baseline, week 26 and 52, and MRI-PDFF at baseline and week
52. The primary outcome will be a difference in change of liver fat content (measured by
MRI-PDFF) at week 52 from baseline between the two groups.
The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis in
NAFLD patients without DM.
Description:
Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25%.
Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are
associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2)
inhibitors are antidiabetic drugs that reduce hepatic fat content in patients with DM, which
is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients
without DM has not been investigated. Magnetic resonance imaging-derived proton density fat
fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than
liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by
transient elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high
accuracy.
The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2
inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration. The
investigators propose a double-blind, randomized, placebo-controlled trial to compare the
effects of empagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in
reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients without DM. A total of
98 adult patients will be randomly sampled from the liver clinical in our local hospital.
Empagliflozin 10mg daily will be given to the treatment arm. The placebo pill will be
manufactured to be identical in appearance to the study drug. Eligible subjects will be
followed up until week 52, and will undergo clinical, anthropometric and laboratory
assessments (including liver function test and fasting blood) at baseline, week 6, 12, 26, 40
and 52. They will undergo LSM at baseline, week 26 and 52, and MRI-PDFF at baseline and week
52. The primary outcome will be a difference in change of liver fat content (measured by
MRI-PDFF) at week 52 from baseline between the two groups. The secondary outcomes will be
remission of steatosis (MRI-PDFF <5%) at week 52, reduction of liver fibrosis (LSM) at week
26 and 52, improvement of laboratory results (including liver transaminases and ductal
enzymes, fasting glucose, HbA1c, lipid profile), improvement of anthropometric measurements,
and combined cardiovascular and cerebrovascular events.
The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis and
regress fibrosis in NAFLD patients without DM.