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. 2024 Aug 17;12(8):186.
doi: 10.3390/diseases12080186.

Therapeutic Effects of Semaglutide on Nonalcoholic Fatty Liver Disease with Type 2 Diabetes Mellitus and Obesity: An Open-Label Controlled Trial

Ahmed I Gad  1 , Nevin F Ibrahim  1 , Noura Almadani  2 , Rasha Mahfouz  2 , Hanaa A Nofal  3 , Dina S El-Rafey  3 , Hossam Tharwat Ali  4 , Amr T El-Hawary  1 , Ayman M E M Sadek  1
Affiliations

Therapeutic Effects of Semaglutide on Nonalcoholic Fatty Liver Disease with Type 2 Diabetes Mellitus and Obesity: An Open-Label Controlled Trial

Ahmed I Gad et al. Diseases. .

Abstract

Background: GLP-1 receptor agonists (GLP-1 RAs) have been shown to improve glycemic control and insulin sensitivity and reduce body weight in obese patients with type 2 diabetes mellitus (T2D). This trial sought to evaluate the therapeutic effect of oral and subcutaneous semaglutide in NAFLD and its sequelae in obesity and/or T2D.

Methods: In an open-labelled intervention study, the sample was 180 patients classified into three parallel groups (1:1:1): group I received oral semaglutide, group II patients received injectable semaglutide, and group III received pioglitazone and/or vitamin E. Patients were evaluated at 6 and 12 months.

Results: There was a substantial improvement in lipid profile, liver enzymes, and body mass index, especially in group II. As for HDL, only group II showed a consistent increase at both 6 months (51 ± 4.62 mg/dL) and 12 months (50.08 ± 2.45 mg/dL) compared with baseline (45.6 ± 6.37 mg/dL) (p-value < 0.001). Despite the non-significant difference in NAFLD fibrosis score (NFS) (p-value = 0.45 and 0.63), group II had significantly lower scores of the fibrosis-4 score (FIB-4), liver stiffness measurement (LSM), and controlled attenuation parameter (CAP) at 6 and 12 months (p-value < 0.001). Conclusions: Semaglutide improves lipid profile, liver steatosis, and fibrosis parameters and reduces the BMI in T2D and obese patients with NAFLD.

Keywords: GLP-1; clinical trial; diet study; nonalcoholic fatty liver disease; obesity; semaglutide; type 2 diabetes mellitus.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Enrollment process of the study patients.
Figure 2
Figure 2
Controlled attenuation parameter (CAP) of the study groups through study timepoints. The p-value is for ANOVA test, NS: non-significant, ** highly significant p-value (<0.001).
Figure 3
Figure 3
Liver stiffness measurement (LSM) of the study groups through study timepoints. The p-value is for ANOVA test, NS: non-significant, ** highly significant p-value (<0.001).
Figure 4
Figure 4
Fibrosis-4 score (FIB-4) of the study groups through study timepoints. The p-value is for Kruskal–Wallis test, NS: nob-significant, * significant p-value (<0.05).
See this image and copyright information in PMC

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