Semaglutide combined with empagliflozin vs. monotherapy for non-alcoholic fatty liver disease in type 2 diabetes: Study protocol for a randomized clinical trial

• DOI: 10.1371/journal.pone.0302155
• Publication Date: 2024-05-03T17:26:14Z
• Authors: Yu-Hao Lin; Zhi-Jun Zhang; Jin-Qing Zhong; Zhi-Yi Wang; Yi-Ting Peng; Yan-Mei Lin; Huo-Ping Zhang; Jian-Qing Tian
• Keywords: Empagliflozin; Semaglutide

Background Nonalcoholic fatty liver disease (NAFLD) is strongly associated with type 2 diabetes mellitus (T2DM). Lifestyle intervention remains a preferred treatment modality for NAFLD. The glucagon-like peptide (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been developed as new glucose-lowering drugs, which can improve via an insulin-independent effect. However, studies exploring the efficacy of GLP-1 combined SGLT-2 in patients NAFLD T2DM are scanty. Thus, present randomised controlled trial aims at comparing safety semaglutide plus empagliflozin each alone T2DM. Methods This 52-week double-blinded, randomised, parallel-group, active-controlled evaluates effects semaglutide, + 105 eligible overweight/obese subjects primary outcome will be change from baseline to week 52 attenuation parameter, free acid glucagon. Secondary endpoints include changes stiffness measurement, enzymes, blood glucose, lipid levels, renal function, electrolyte balances, minerals bone metabolism, cytokines, high-sensitivity C-reactive protein, ferritin, anthropometric indicators, nonalcoholic fibrosis score, 4 score homeostatic model assessment insulin resistance. In addition, intention-to-treat, interim analysis performed. Discussion clinical involves multi-disciplinary approach explore synergistic combination empagliflozin. results provide important insights into mechanisms and/or Trial registration study has registered Chinese Clinical Registry ( ChiCTR2300070674 ).