Trial Outcomes & Findings for The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting (NCT NCT07021443)

NCT ID: NCT07021443

Last Updated: 2025-08-26

Results Overview

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

From time of infomed consent till 1 year after signing informed consent.

Results posted on

2025-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=48 Participants Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
Age, Continuous	58 years n=48 Participants
Sex: Female, Male Female	19 Participants n=48 Participants
Sex: Female, Male Male	29 Participants n=48 Participants
prevalence prevalence of obesity in patients participating	48 participants n=48 Participants
prevalence prevalence of T2DM in patients participating	48 participants n=48 Participants
prevalence prevalence of liver steatosis in patients participating	48 participants n=48 Participants
Use of statins at initiation of GLP1a patients using statins	38 Participants n=48 Participants
Use of statins at initiation of GLP1a patients not using statins	10 Participants n=48 Participants
Indication of GLP1a T2DM	46 Participants n=48 Participants
Indication of GLP1a Obesity	2 Participants n=48 Participants

PRIMARY outcome

Timeframe: From time of infomed consent till 1 year after signing informed consent.

Population: 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.

Outcome measures

Outcome measures
Measure	Study Group n=48 Participants Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
Serum Markers (sfG) to Follow the Evolution of Liver Damage AST under ULN at month 0	22.59 U/L Standard Deviation 7.997
Serum Markers (sfG) to Follow the Evolution of Liver Damage ALT under ULN at month 0	28.51 U/L Standard Deviation 14.716
Serum Markers (sfG) to Follow the Evolution of Liver Damage GGT under ULN at month 0	38.59 U/L Standard Deviation 22.542
Serum Markers (sfG) to Follow the Evolution of Liver Damage AST under ULN at month 12	21.34 U/L Standard Deviation 8.515
Serum Markers (sfG) to Follow the Evolution of Liver Damage ALT under ULN at month 12	27.58 U/L Standard Deviation 15.448
Serum Markers (sfG) to Follow the Evolution of Liver Damage GGT under ULN at month 12	36.68 U/L Standard Deviation 22.534
Serum Markers (sfG) to Follow the Evolution of Liver Damage AST above ULN at month 0	37.86 U/L Standard Deviation 2.61
Serum Markers (sfG) to Follow the Evolution of Liver Damage ALT above ULN at month 0	45.54 U/L Standard Deviation 13.457
Serum Markers (sfG) to Follow the Evolution of Liver Damage GGT above ULN at month 0	71 U/L Standard Deviation 22.857
Serum Markers (sfG) to Follow the Evolution of Liver Damage AST above ULN at month 12	29.43 U/L Standard Deviation 13.501
Serum Markers (sfG) to Follow the Evolution of Liver Damage ALT above ULN at month 12	38.45 U/L Standard Deviation 17.218
Serum Markers (sfG) to Follow the Evolution of Liver Damage GGT above ULN at month 12	63 U/L Standard Deviation 30.054

PRIMARY outcome

Timeframe: From time of signing the ICF till 1 year after given informed consent

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

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.

Outcome measures

Outcome measures
Measure	Study Group n=39 Participants Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
Fatty Liver Index (FLI) FLI at month 0	88.92 units on a scale Standard Deviation 10.31
Fatty Liver Index (FLI) FLI at month 12	80.39 units on a scale Standard Deviation 15.3

PRIMARY outcome

Timeframe: From time of signing the ICF till 1 year after given informed consent

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

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).

Outcome measures

Outcome measures
Measure	Study Group n=41 Participants Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
FIB-4 Index FIB-4 at month 0	1.17 units on a scale Standard Deviation 0.54
FIB-4 Index FIB-4 at month 12	1.09 units on a scale Standard Deviation 0.56

PRIMARY outcome

Timeframe: From time of infomed consent till 1 year after signing informed consent.

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

Outcome measures

Outcome measures
Measure	Study Group n=48 Participants Obese and/or diabetic patients with objectified NAFLD starting a GLP-1 analogue
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage HbA1c at month 0	8.16 percentage Standard Deviation 0.996
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage HbA1c at month 12	7.14 percentage Standard Deviation 1.18

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. dr. Hendrik Reynaert

UZ Brussel

Phone: +32 2 477 68 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place