• Grit Andersen, Leona Plum-Mörschel, Paul D Hockings, Anni Morsing, Mads S Palle, Olivia Svolgaard, and Anne Flint.
• Project Development, Profil, Neuss, Germany. Grit.Andersen@profil.com.
• Adv Ther. 2020 Dec 1; 37 (12): 4866-4876.

IntroductionNon-alcoholic fatty liver disease (NAFLD), one of the most common liver diseases, is associated with liver-related complications and metabolic comorbidities. The phenotype is wide, ranging from simple steatosis to non-alcoholic steatohepatitis with advanced fibrosis. In this analysis of a phase 1 trial, clinical characteristics of screened subjects with NAFLD were studied according to the extent of fibrosis assessed using magnetic resonance elastography (MRE).MethodsOne hundred ninety-four subjects with body mass index (BMI) of 25-40 kg/m2 and suspected NAFLD were assessed by MRE and grouped by MRE thresholds as a proxy for fibrosis staging (groups 0-4). Data were summarized by group levels, and correlation analyses between MRE values and clinical parameters (including magnetic resonance imaging-proton density fat fraction) were performed.ResultsMost subjects had MRE values in the lower range (groups 0-1; N = 148). Type 2 diabetes (T2D) and BMI > 35 kg/m2 were more frequent in groups with higher than lower MRE values. Subjects in the highest MRE groups also tended to be older and have higher liver enzyme concentrations compared with lower MRE groups. No, or weak, correlations were found between MRE values and clinical parameters (all r values ≤ 0.45).ConclusionsThere was considerable variation and overlap in clinical characteristics across the spectrum of liver stiffness. Although groups with high MRE values generally included more subjects with T2D and obesity, and had higher age and concentrations of liver enzymes, the clinical characteristics did not strongly correlate with MRE scores in this population.Trial RegistrationRegistered on Clinicaltrials.gov on November 29, 2017 (NCT03357380).

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