A randomized triple-blind controlled clinical trial evaluation of sitagliptin in the treatment of patients with non-alcoholic fatty liver diseases without diabetes

Azam Doustmohammadian, Ahmad Nezhadisalami, Fahimeh Safarnezhad Tameshke, Nima Motamed, Mansooreh Maadi, Mohammad Farahmand, Masoudreza Sohrabi, Cain C. T. Clark, Hossein Ajdarkosh, Amir Hossein Faraji, Mehdi Nikkhah, Elham Sobhrakhshankhah, Ramin Ebrahimi, Farhad Zamani

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    The current study aimed to evaluate the efficacy of sitagliptin vs. placebo in treating non-alcoholic fatty liver disease (NAFLD). In a triple-blind randomized clinical trial, we assigned 120 eligible subjects with NAFLD to receive daily dosing of 50 mg sitagliptin (n = 60) or the placebo (n = 60) for 56 weeks and lifestyle modification in both groups. Laboratory and anthropometric outcomes were measured, and liver stiffness was assessed using a fibroscan. The primary outcome measures were changes from baseline in fibrosis scores and liver transferases. Out of 120 patients randomized into sitagliptin and placebo groups, 76 patients completed the trial, of whom 44 were in the sitagliptin and 32 in the placebo groups. Patients receiving sitagliptin showed a significant decrease in the fibrosis scores (P = 0.001). The reductions in the alanine aminotransferase (AST) (P = 0.036) and aspartate AST (P < 0.001) levels were also statistically significant. The effect of sitagliptin in reducing fibrosis scores was significantly greater in normal-weight and overweight individuals than in obese individuals (p = 0.036, and p = 0.018, respectively), whereas the effects of sitagliptin on AST levels were greater among overweight/obese patients (p = 0.028, and p = 0.016, respectively). Sitagliptin reduced fibrosis scores and liver enzymes in NAFLD patients after 56 weeks of therapy. The changes in fibrosis scores were more prominent in patients with normal weight and overweight than obese patients, whereas the effects on AST levels were greater among overweight/obese patients. Other randomized trials with larger sample sizes and longer treatment durations may be required before precise results can be reached. Clinical Trial Registration: [https://www.irct.ir/trial/46140], identifier [IRCT20140430017505N2].
    Original languageEnglish
    Article number937554
    Number of pages11
    JournalFrontiers in Medicine
    Early online date28 Jul 2022
    Publication statusPublished - 28 Jul 2022

    Bibliographical note

    This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.


    This work was funded by the Gastrointestinal and liver Diseases Research Center (GILDRC), Iran University of Medical Sciences (IUMS) (grant no. 97-3-30-13227).


    • Medicine
    • sitagliptin
    • NAFLD
    • clinical trial design
    • fibrosis scores
    • liver enzymes


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