TY  - JOUR
A1  - Flint, Anne
A1  - Andersen, Grit
A1  - Hockings, Paul
A1  - Johansson, Lars
A1  - Morsing, Anni
A1  - Sundby Palle, Mads
A1  - Vogl, Thomas J.
A1  - Loomba, Rohit
A1  - Plum-Mörschel, Leona
T1  - Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging
T2  - Alimentary pharmacology & therapeutics
N2  - Background: Glucagon-like peptide-1 receptor agonists may be a treatment option in patients with non-alcoholic fatty liver disease (NAFLD). Aims: To investigate the effects of semaglutide on liver stiffness and liver fat in subjects with NAFLD using non-invasive magnetic resonance imaging (MRI) methods. Methods: This randomised, double-blind, placebo-controlled trial enrolled subjects with liver stiffness 2.50-4.63 kPa by magnetic resonance elastography (MRE) and liver steatosis ≥10% by MRI proton density fat fraction (MRI-PDFF). The primary endpoint was change from baseline to week 48 in liver stiffness assessed by MRE. Results: Sixty-seven subjects were randomised to once-daily subcutaneous semaglutide 0.4 mg (n = 34) or placebo (n = 33). Change from baseline in liver stiffness was not significantly different between semaglutide and placebo at week 48 (estimated treatment ratio 0.96 (95% CI 0.89, 1.03; P = 0.2798); significant differences in liver stiffness were not observed at weeks 24 or 72. Reductions in liver steatosis were significantly greater with semaglutide (estimated treatment ratios: 0.70 [0.59, 0.84], P = 0.0002; 0.47 [0.36, 0.60], P < 0.0001; and 0.50 [0.39, 0.66], P < 0.0001) and more subjects achieved a ≥ 30% reduction in liver fat content with semaglutide at weeks 24, 48 and 72, (all P < 0.001). Decreases in liver enzymes, body weight and HbA1c were also observed with semaglutide. Conclusions: The change in liver stiffness in subjects with NAFLD was not significantly different between semaglutide and placebo. However, semaglutide significantly reduced liver steatosis compared with placebo which, together with improvements in liver enzymes and metabolic parameters, suggests a positive impact on disease activity and metabolic profile. ClinicalTrials.gov identifier: NCT03357380
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/64497
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-644977
SN  - 1365-2036
N1  - This study was funded by Novo Nordisk A/S, Denmark. The writing of this paper was funded by Novo Nordisk A/S, Denmark. Writing support was provided by Andy Bond and Paul Barlass of Axis, a division of Spirit Medical Communications Group Limited, and was funded by Novo Nordisk A/S, Denmark.
VL  - 54
IS  - 9
SP  - 1150
EP  - 1161
PB  - Blackwell Science
CY  - Oxford
ER  -