N/A
Completed N=50
The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting
Source: ClinicalTrials.gov NCT07021443 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Serum Markers (sfG) to Follow the Evolution of Liver Damage — 22.59; 28.51; 38.59; 21.34 U/L
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Markers (sfG) to Follow the Evolution of Liver Damage |
22.59; 28.51; 38.59; 21.34; 27.58; 36.68 | — |
| PRIMARY Fatty Liver Index (FLI) |
88.92; 80.39 | — |
| PRIMARY FIB-4 Index |
1.17; 1.09 | — |
| PRIMARY Serum Markers (HbA1c) to Follow the Evolution of Liver Damage |
8.16; 7.14 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT07021443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.