01
QoL subscore:
The improvement was significant in fatigue subscore at month 6 (LSMD: 0.31; p=0.0229)3 Exploratory results:
EPL + SoC significantly reduced HbA1C levels compared with placebo + SoC at 6 months4 A phase 4 multicenter, multinational, double-blind, randomized, placebo-controlled, parallel-group study, conducted in Germany and Poland (study duration was 10 months) EXCEL study design1 Primary outcome:
A statistically significant reduction in CAP score was observed in the EPL vs placebo group at 6 months (p=0.0269)3
Reduction in CAP score was observed as early as 3 months and sustained at 9 months3 CAP, controlled attenuation parameter; CLDQ, chronic liver disease questionnaire; EPL, essential phosphilipids; EXCEL, Exploring Efficacy of Essentiale in Fatty Liver Disease; HbA1c, glycated Haemoglobin A1c; LSMD, least square mean difference; MASH, metabolic-dysfunction associated steatohepatitis; MASLD, metabolic-dysfunction associated steatotic liver disease; MMRM, mixed-effects model with repeated measuresmITT, modified intention-to-treat; QoL, quality of life; SE, standard error; SoC, standard-of-care (lifestyle modification [diet and physical activity/exercise]) ; T2DM, type 2 diabetes mellitus. 1) Stefan N, et al. Trials. 2024;25:374; 2) Gundermann KJ, et al. Pharmacol Rep. 2016;3:643–659; 3) Stefan N, et al. Poster presented at: AASLD; November 15 – 19, 2024; San Diego, CA, USA. (Poster ID: 5037); 4) Stefan N, et al. Poster presented at: SLD-EASL Summit; January 23 – 25, 2025; Estoril, Portugal. (Poster ID: PO7-01). Visit 4 Visit 3 Visit 1 Visit 2 Active ingredient of EPL: 1,2-dilinoleoylphosphatidylcholine (DLPC)2 Arm A: EPL + SoC (N=97) Arm B: Placebo + SoC (N=96) 1:1
R Treatment period 3 months 3 months 3 months First study to systematically assess steatosis and QoL improvement with EPL (Opella®) via CAP and CLDQ-MASLD/MASH questionnaire, respectively, in patients with MASLD associated with T2DM and/or hyperlipidemia and/or obesity1 What is EXCEL clinical trial? Results: Total of 193 patients were enrolled; of these 165 constituted mITT set *P< 0.05; #Analysis was carried out in mITT population using MMRM; The dotted line indicates a 3 months follow-up after end of treatment EPL + SoC, demonstrated significant efficacy in reducing hepatic steatosis, showed overall numerical QoL improvement and significant improvement in the fatigue subgroup, in patients with MASLD at 6 months, compared to placebo + SoC The overall safety profile of EPL + SoC group was comparable with that of placebo + SoC3 Safety EPL improved QoL fatigue subscore * Secondary outcome:
At month 6, CLDQ-MASLD/MASH total score was numerically improved in EPL vs placebo group (LSMD: 0.17; p=0.2445)3 R, randomization PromoMats ID: MAT-GLB-2502572; Date of approval: May 2025 Focusing on metabolic risk of MASLD/MAFLD. EXCEL study design and major outcomes Professor Norbert Stefan
Department of Internal Medicine IV, University Hospital Tübingen, Tübingen, Germany<br>
