Non-Alcoholic Fatty Liver DiseaseGLP1_NAFLDNCT07021443

The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting

An observational study of Non-Alcoholic Fatty Liver Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Alcoholic Fatty Liver Disease
What is being tested?: non-interventional
How many people: 50 participants
Where: 1 siteBelgium
Study dates: 9 Oct 2023to 12 May 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants will be recruited from consultations in the diabetes- and obesity clinic in UZ Brussel. All diabetic and/or obese patients with objectified NAFLD starting a GLP-1 analogue, or whom have started a GLP-1 analogue 12 months prior, will be considered as possible candidates. Inclu-sion is definite after it is established that patients comply to all inclusion- and exclusion criteria and they agree to the informed consent.

Who may be able to join

The patient is older than 18 years old.
The patient has obesity, defined as a BMI of 30 or higher; and/or the patient suffers from T2DM, defined as a twice measured sfG of 125 mg/dl or higher, or a sfG of 100 to 125 mg/dl and a twice measured oral glucose tolerance test (OGTT) with a serum glucose (sG) of 200 mg/dl, or higher after 2 hours, or a random sG of 200 mg/dl or higher in symptomatic patients.
The patient suffers from NAFLD in any stage, except cirrhosis. This has to be objec-tively diagnosed by either a CAP fibroscan (cutoff: > 238 dB/m); or by the calculated NAFLD liver fat score (cutoff: > -0,64), at least one of which has to be positive.
The patient is starting a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study; or the patient has started a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study 12 months prior.
If the patient is part of the retro-prospective branch data collected 12 months prior include at least a (CAP) fibroscan, a blood sample (measuring AST, ALT, GGT, sfG, sfI, HbA1c, HDL, LDL, total cholesterol and platelets) and a physical examination (measuring blood pressure, waist circumference, weight and length).

Who cannot join

The patient suffers from alcohol induced fatty liver disease. Macrocytic anemia; de-creased vitamin B12 and folic acid; increased GGT, bilirubin, ferritin, TG and AST/ALT ratio can be used as serum markers of alcohol abuse. Interpretation of these results will be the left to the patient's clinician and their clinical expertise. Alterna-tively a weekly alcohol consumption of 21 units for men and 14 units for women can be used as a cutoff.
The patient suffers from drug induced liver steatosis. Drugs warranting exclusion include glucocorticoids, amiodarone, tamoxifen, methotrexate, valproate, tetracycline and chemotherapeutic agents.
The patient suffers from any other chronic liver disease. These will be checked trough lab test results in the patients file.
The patient has liver cirrhosis, defined as a fibroscan score of 14 kPa or more; or a FIB-4 index of > 2,67. Elastography
The patient is pregnant at time of enrolment or at any time during the study.
The patient refuses to agree to the informed consent.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Brussel
Brussels, 1090

Other trials in Belgium

About this study

This study aims to measure the effect of GLP-1 analogues on non-alcoholic fatty liver disease in patients with diabetes and/or obesity in a clinical context. Previous studies showed a positive effect of this medication, but these studies always took place in highly controlled settings. The question is to what extent liver values evolve in a non-controlled context. The real effect and thus the clinical utility of GLP-1 analogues will be measured.

Read the detailed description

Patients in whom a GLP-1 analogue is started (as it would be outside the context of this study) may be recruited. Patients in whom a GLP-1 analogue was started 12 months earlier are also eligible. Once they were screened on the inclusion and exclusion criteria and they took into account and signed the informed consent, they can be definitively included. Participants will be followed for 12 months. There are 2 contact points, the first on the start day and the second after 12 months. During this period, serum markers of liver injury, type 2 diabetes and dyslipidaemia are monitored. With these, additional scores for hepatic steatosis (NAFLD liver fat score) and fibrosis (FIB-4 index) are calculated. A fibroscan (or elastography) is also performed to monitor the evolution of hepatic steatosis and fibrosis. The evolution of data is statistically analysed and hereby compared with the starting points.

Conditions: Non-Alcoholic Fatty Liver Disease
Being tested: non-interventional
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

non-interventionalOther
non-interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Markers (sfG) to Follow the Evolution of Liver Damage
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.
Measured: From time of infomed consent till 1 year after signing informed consent.
Fatty Liver Index (FLI)
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the Fatty Liver Index to evaluate steatosis.
The Fatty Liver Index (FLI) (calculated using TG, GGT, abdominal waist circumference and BMI) was employed to monitor the risk for steatosis. FLI: < 30 as low risk, 30 to < 60 as intermediate risk, and ≥ 60 as high risk for liver steatosis.
Measured: From time of signing the ICF till 1 year after given informed consent
FIB-4 Index
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the FIB-4 index to evaluate fibrosis.
The FIB-4 index is a non-invasive tool used to assess the likelihood of advanced liver fibrosis in individuals, particularly those with conditions like non-alcoholic fatty liver disease (NAFLD) or type 2 diabetes. It combines age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count to generate a score that helps categorize patients into low, intermediate, or high risk for significant liver scarring.
FIB-4 index: < 1,3 for patients < 64 years or < 2 for those > 64 years as low risk (F0-1 = mild fibrosis); 1,3 - 2,67 (< 64 years) or 2 - 2,67 (> 64 years) as intermediate risk (F2-3 = moderate fibrosis); and > 2,67 as high risk for advanced fibrosis (F4 = severe fibrosis to cirrhosis).
Measured: From time of signing the ICF till 1 year after given informed consent
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.
Measured: From time of infomed consent till 1 year after signing informed consent.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 202312 May 2025

First posted15 Jun 2025
Study start9 Oct 2023
Primary completion26 Oct 2023
Study completion12 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07021443
Sponsor's protocol ID: GLP1_NAFLD
Acronym: GLP1_NAFLD
Status last verified: Aug 2025
First submitted: 9 May 2023
Last updated: 26 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

All Non-Alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting
ClinicalTrials.gov ID: NCT07021443
Acronym / sponsor ID: GLP1_NAFLD / GLP1_NAFLD
Conditions: Non-Alcoholic Fatty Liver Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Universitair Ziekenhuis BrusselUniversity, hospital or other
Study start: 9 Oct 2023 (actual)
Primary completion: 26 Oct 2023 (actual)
Study completion: 12 May 2025 (actual)
First posted: 15 Jun 2025 (actual)
Results: Posted 26 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be recruited from consultations in the diabetes- and obesity clinic in UZ Brussel. All diabetic and/or obese patients with objectified NAFLD starting a GLP-1 analogue, or whom have started a GLP-1 analogue 12 months prior, will be considered as possible candidates. Inclu-sion is definite after it is established that patients comply to all inclusion- and exclusion criteria and they agree to the informed consent.

Key inclusion criteria (5 listed)

The patient is older than 18 years old.
The patient has obesity, defined as a BMI of 30 or higher; and/or the patient suffers from T2DM, defined as a twice measured sfG of 125 mg/dl or higher, or a sfG of 100 to 125 mg/dl and a twice measured oral glucose tolerance test (OGTT) with a serum glucose (sG) of 200 mg/dl, or higher after 2 hours, or a random sG of 200 mg/dl or higher in symptomatic patients.
The patient suffers from NAFLD in any stage, except cirrhosis. This has to be objec-tively diagnosed by either a CAP fibroscan (cutoff: > 238 dB/m); or by the calculated NAFLD liver fat score (cutoff: > -0,64), at least one of which has to be positive.
The patient is starting a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study; or the patient has started a GLP-1 analogue as treatment for T2DM or obesity as would be prescribed outside of this study 12 months prior.
If the patient is part of the retro-prospective branch data collected 12 months prior include at least a (CAP) fibroscan, a blood sample (measuring AST, ALT, GGT, sfG, sfI, HbA1c, HDL, LDL, total cholesterol and platelets) and a physical examination (measuring blood pressure, waist circumference, weight and length).

Key exclusion criteria (6 listed)

The patient suffers from alcohol induced fatty liver disease. Macrocytic anemia; de-creased vitamin B12 and folic acid; increased GGT, bilirubin, ferritin, TG and AST/ALT ratio can be used as serum markers of alcohol abuse. Interpretation of these results will be the left to the patient's clinician and their clinical expertise. Alterna-tively a weekly alcohol consumption of 21 units for men and 14 units for women can be used as a cutoff.
The patient suffers from drug induced liver steatosis. Drugs warranting exclusion include glucocorticoids, amiodarone, tamoxifen, methotrexate, valproate, tetracycline and chemotherapeutic agents.
The patient suffers from any other chronic liver disease. These will be checked trough lab test results in the patients file.
The patient has liver cirrhosis, defined as a fibroscan score of 14 kPa or more; or a FIB-4 index of > 2,67. Elastography
The patient is pregnant at time of enrolment or at any time during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
non-interventionalnon-interventional	Other	–

Primary outcome

Serum Markers (sfG) to Follow the Evolution of Liver Damage
Time frame: From time of infomed consent till 1 year after signing informed consent.
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.
Fatty Liver Index (FLI)
Time frame: From time of signing the ICF till 1 year after given informed consent
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the Fatty Liver Index to evaluate steatosis. The Fatty Liver Index (FLI) (calculated using TG, GGT, abdominal waist circumference and BMI) was employed to monitor the risk for steatosis. FLI: < 30 as low risk, 30 to < 60 as intermediate risk, and ≥ 60 as high risk for liver steatosis.
FIB-4 Index
Time frame: From time of signing the ICF till 1 year after given informed consent
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to calculate the FIB-4 index to evaluate fibrosis. The FIB-4 index is a non-invasive tool used to assess the likelihood of advanced liver fibrosis in individuals, particularly those with conditions like non-alcoholic fatty liver disease (NAFLD) or type 2 diabetes. It combines age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count to generate a score that helps categorize patients into low, intermediate, or high risk for significant liver scarring. FIB-4 index: < 1,3 for patients < 64 years or < 2 for those > 64 years as low risk (F0-1 = mild fibrosis); 1,3 - 2,67 (< 64 years) or 2 - 2,67 (> 64 years) as intermediate risk (F2-3 = moderate fibrosis); and > 2,67 as high risk for advanced fibrosis (F4 = severe fibrosis to cirrhosis).
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage
Time frame: From time of infomed consent till 1 year after signing informed consent.
This study aims to measure the effect of GLP-1 analogues on liver steatosis and fibrosis in diabetic and obese patients in a real-life clinical setting. Serum markers will be used to follow the evolution of liver damage.

Results and safety

Results posted to the registry on 26 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	50	48

Primary outcome: Serum Markers (sfG) to Follow the Evolution of Liver Damage

Time frame: From time of infomed consent till 1 year after signing informed consent.. Mean (Standard Deviation). Unit: U/L

Measure	Study Group n = 48
AST under ULN at month 0	22.59 (7.997)
ALT under ULN at month 0	28.51 (14.716)
GGT under ULN at month 0	38.59 (22.542)
AST under ULN at month 12	21.34 (8.515)
ALT under ULN at month 12	27.58 (15.448)
GGT under ULN at month 12	36.68 (22.534)
AST above ULN at month 0	37.86 (2.61)
ALT above ULN at month 0	45.54 (13.457)

Population analysed: To better understand potential therapeutic effects in patients with more pronounced liver involvement, subjects presenting with liver enzymes levels above the ULN at baseline were analyzed separately also. no AST under ULN was available at month 12 (m12) for 3 patients. no ALT under ULN was available at m12 for 1 patients. no GGT under ULN was available at m12 for 2 patients. no ALT above ULN was available at m12 for 2 patients. no GGT above ULN was available at m12 for 1 patients.

Primary outcome: Fatty Liver Index (FLI)

Time frame: From time of signing the ICF till 1 year after given informed consent. Mean (Standard Deviation). Unit: units on a scale

Measure	Study Group n = 39
FLI at month 0	88.92 (10.31)
FLI at month 12	80.39 (15.3)

Population analysed: no FLI was available at month 12 for 11 patients.

Primary outcome: FIB-4 Index

Time frame: From time of signing the ICF till 1 year after given informed consent. Mean (Standard Deviation). Unit: units on a scale

Measure	Study Group n = 41
FIB-4 at month 0	1.17 (0.54)
FIB-4 at month 12	1.09 (0.56)

Population analysed: no FIB-4 score was available for 4 patients at month 12.

Primary outcome: Serum Markers (HbA1c) to Follow the Evolution of Liver Damage

Time frame: From time of infomed consent till 1 year after signing informed consent.. Mean (Standard Deviation). Unit: percentage

Measure	Study Group n = 48
HbA1c at month 0	8.16 (0.996)
HbA1c at month 12	7.14 (1.18)

Population analysed: no HbA1c was available for 3 patients at month 12.

Adverse events

Time frame: adverse events were followed for 1 year after informed consent was given.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Non-Alcoholic Fatty Liver Disease

Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Alcoholic Fatty Liver Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Markers (sfG) to Follow the Evolution of Liver Damage (time frame: From time of infomed consent till 1 year after signing informed consent.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.