A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis
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Background & Aims Efruxifermin has shown clinical efficacy in patients with non-alcoholic steatohepatitis (NASH) and F1–F3 fibrosis. The primary objective of the BALANCED Cohort C was to assess the safety and tolerability of efruxifermin in patients with compensated NASH cirrhosis. Methods Patients with NASH and stage 4 fibrosis (n = 30) were randomized 2:1 to receive efruxifermin 50 mg (n = 20) or placebo (n = 10) once-weekly for 16 weeks. The primary endpoint was safety and tolerability of efruxifermin. Secondary and exploratory endpoints included evaluation of non-invasive markers of liver injury and fibrosis, glucose and lipid metabolism, and changes in histology in a subset of patients who consented to end-of-study liver biopsy. Results Efruxifermin was safe and well-tolerated; most adverse events (AEs) were grade 1 (n = 7, 23.3%) or grade 2 (n = 19, 63.3%). The most frequent AEs were gastrointestinal, including transient, mild to moderate diarrhea, and/or nausea. Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism. Sixteen-week treatment with efruxifermin was associated with significant reductions in non-invasive markers of fibrosis including Pro-C3 (least squares mean change from baseline [LSMCFB] −9 μg/L efruxifermin vs. −3.4 μg/L placebo; p = 0.0130) and ELF score (−0.4 efruxifermin vs. +0.4 placebo; p = 0.0036), with a trend towards reduced liver stiffness (LSMCFB −5.7 kPa efruxifermin vs. −1.1 kPa placebo; n.s.). Of 12 efruxifermin-treated patients with liver biopsy after 16 weeks, 4 (33%) achieved fibrosis improvement of at least one stage without worsening of NASH, while an additional 3 (25%) achieved resolution of NASH, compared to 0 of 5 placebo-treated patients. Conclusions Efruxifermin appeared safe and well-tolerated with encouraging improvements in markers of liver injury, fibrosis, and glucose and lipid metabolism following 16 weeks of treatment, warranting confirmation in larger and longer term studies. Lay summary Cirrhosis resulting from non-alcoholic steatohepatitis (NASH), the progressive form of non-alcoholic fatty liver disease, represents a major unmet medical need. Currently there are no approved drugs for the treatment of NASH. This proof-of-concept randomized, double-blind clinical trial demonstrated the potential therapeutic benefit of efruxifermin treatment compared to placebo in patients with cirrhosis due to NASH. Clinical Trial Number NCT03976401
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Adiponectin levels and insulin sensitivity increased with both substances despite, if any, only minor changes in body weight.
“Of interest, adiponectin levels and insulin sensitivity increased with both substances despite, if any, only minor changes in body weight [202,203].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [203]
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Chalasani, N., Younossi, Z., Lavine, J. E., Charlton, M., Cusi, K., Rinella, M., Harrison, S. A., Brunt, E. M., & Sanyal, A. J. (2018) · Hepatology · doi:10.1002/hep.29367 · Cited by 7,239 · see citing works
Self-citationNonalcoholic fatty liver disease: a spectrum of clinical and pathological severity.
MATTEONI, C., YOUNOSSI, Z., GRAMLICH, T., BOPARAI, N., LIU, Y., & MCCULLOUGH, A. (1999) · Gastroenterology · doi:10.1016/s0016-5085(99)70506-8 · Cited by 3,345 · see citing works
Angulo, P., Kleiner, D. E., Dam-Larsen, S., Adams, L. A., Bjornsson, E. S., Charatcharoenwitthaya, P., Mills, P. R., Keach, J. C., Lafferty, H. D., Stahler, A., et al. (2015) · Gastroenterology · doi:10.1053/j.gastro.2015.04.043 · Cited by 2,987 · see citing works
Ekstedt, M., Hagström, H., Nasr, P., Fredrikson, M., Stål, P., Kechagias, S., & Hultcrantz, R. (2015) · Hepatology · doi:10.1002/hep.27368 · Cited by 2,287 · see citing works
Dulai, P. S., Singh, S., Patel, J., Soni, M., Prokop, L. J., Younossi, Z., Sebastiani, G., Ekstedt, M., Hagstrom, H., Nasr, P., et al. (2017) · Hepatology · doi:10.1002/hep.29085 · Cited by 1,965 · see citing works
The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe
Younossi, Z. M., Blissett, D. B., Blissett, R., Henry, L. L., Stepanova, M., Younossi, Y., Racila, A., Hunt, S., & Beckerman, R. (2016) · Hepatology · doi:10.1002/hep.28785 · Cited by 1,289 · see citing works
Xu, J., Lloyd, D. J., Hale, C., Stanislaus, S., Chen, M., Sivits, G., Vonderfecht, S., Hecht, R., Li, Y.-S., Lindberg, R. A., et al. (2009) · Diabetes · doi:10.2337/db08-0392 · Cited by 1,151 · see citing works
Taylor, R. S., Taylor, R. J., Bayliss, S., Hagström, H., Nasr, P., Schattenberg, J. M., Ishigami, M., Toyoda, H., Wai-Sun Wong, V., Peleg, N., et al. (2020) · Gastroenterology · doi:10.1053/j.gastro.2020.01.043 · Cited by 1,069 · see citing works
Fibroblast Growth Factor 21 Corrects Obesity in Mice
Coskun, T., Bina, H. A., Schneider, M. A., Dunbar, J. D., Hu, C. C., Chen, Y., Moller, D. E., & Kharitonenkov, A. (2008) · Endocrinology · doi:10.1210/en.2008-0816 · Cited by 1,031 · see citing works
Self-citationNewsome, P. N., Sasso, M., Deeks, J. J., Paredes, A. H., Boursier, J., Chan, W., Yilmaz, Y. N., Czernichow, S., Zheng, M., Wong, V. W., et al. (2020) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(19)30383-8 · Cited by 824 · see citing works
Self-citationA Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH
Francque, S. M., Bedossa, P., Ratziu, V., Anstee, Q. M., Bugianesi, E., Sanyal, A. J., Loomba, R., Harrison, S. A., Balabanska, R., Mateva, L., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2036205 · Cited by 801 · see citing works
Self-citation2019 Global NAFLD Prevalence: A Systematic Review and Meta-analysis
Le, M. H., Yeo, Y. H., Li, X., Li, J., Zou, B., Wu, Y., Ye, Q., Huang, D. Q., Zhao, C., Zhang, J., et al. (2022) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.12.002 · Cited by 711 · see citing works
Lin, Z., Tian, H., Lam, K. S. L., Lin, S., Hoo, R. C. L., Konishi, M., Itoh, N., Wang, Y., Bornstein, S. R., Xu, A., et al. (2013) · Cell Metabolism · doi:10.1016/j.cmet.2013.04.005 · Cited by 691 · see citing works
Noureddin, M., Vipani, A., Bresee, C. J., Todo, T., Kim, I. K., Alkhouri, N., Setiawan, V. W., Tran, T. T., Ayoub, W. S., Lu, S. C.-L., et al. (2018) · The American Journal of Gastroenterology · doi:10.1038/s41395-018-0088-6 · Cited by 578 · see citing works
Past, present and future perspectives in nonalcoholic fatty liver disease
Sanyal, A. J. (2019) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-019-0144-8 · Cited by 522 · see citing works
Harrison, S. A., Wong, V. W.-S., Okanoue, T., Bzowej, N., Vuppalanchi, R., Younes, Z., Kohli, A., Sarin, S., Caldwell, S. H., Alkhouri, N., et al. (2020) · Journal of Hepatology · doi:10.1016/j.jhep.2020.02.027 · Cited by 497 · see citing works
Self-citationTalukdar, S., Zhou, Y., Li, D., Rossulek, M., Dong, J., Somayaji, V., Weng, Y., Clark, R., Lanba, A., Owen, B. M., et al. (2016) · Cell Metabolism · doi:10.1016/j.cmet.2016.02.001 · Cited by 496 · see citing works
Self-citationHistopathology of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis
Takahashi, Y. (2014) · World Journal of Gastroenterology · doi:10.3748/wjg.v20.i42.15539 · Cited by 492 · see citing works
Harrison, S. A., Abdelmalek, M. F., Caldwell, S., Shiffman, M. L., Diehl, A. M., Ghalib, R., Lawitz, E. J., Rockey, D. C., Schall, R. A., Jia, C., et al. (2018) · Gastroenterology · doi:10.1053/j.gastro.2018.07.006 · Cited by 384 · see citing works
Self-citationHarrison, S. A., Ruane, P. J., Freilich, B. L., Neff, G., Patil, R., Behling, C. A., Hu, C., Fong, E., de Temple, B., Tillman, E. J., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01425-3 · Cited by 368 · cited 19× · see citing works
“The magnitude of improvement in markers of liver injury (ALT, AST, ALP, GGT, urate) associated with efruxifermin treatment was somewhat smaller for Cohort C than for the BALANCED main study.(32) This may be ascribed to a declining population of hepatocytes as fibrosis progresses to cirrhosis,(14) consistent with the l…”
BackgroundResultInfluentialSelf-citationHarrison, S. A., Gawrieh, S., Roberts, K., Lisanti, C. J., Schwope, R. B., Cebe, K. M., Paradis, V., Bedossa, P., Aldridge Whitehead, J. M., Labourdette, A., et al. (2021) · Journal of Hepatology · doi:10.1016/j.jhep.2021.02.034 · Cited by 293 · see citing works
Self-citationHarrison, S. A., Neff, G., Guy, C. D., Bashir, M. R., Paredes, A. H., Frias, J. P., Younes, Z., Trotter, J. F., Gunn, N. T., Moussa, S. E., et al. (2021) · Gastroenterology · doi:10.1053/j.gastro.2020.08.004 · Cited by 280 · see citing works
Self-citationAnstee, Q. M., Lawitz, E. J., Alkhouri, N., Wong, V. W., Romero‐Gomez, M., Okanoue, T., Trauner, M., Kersey, K., Li, G., Han, L., et al. (2019) · Hepatology · doi:10.1002/hep.30842 · Cited by 277 · see citing works
Self-citationFisher, F. M., Chui, P. C., Nasser, I. A., Popov, Y., Cunniff, J. C., Lundasen, T., Kharitonenkov, A., Schuppan, D., Flier, J. S., & Maratos-Flier, E. (2014) · Gastroenterology · doi:10.1053/j.gastro.2014.07.044 · Cited by 263 · see citing works
Charles, E. D., Neuschwander‐Tetri, B. A., Pablo Frias, J., Kundu, S., Luo, Y., Tirucherai, G. S., & Christian, R. (2019) · Obesity · doi:10.1002/oby.22344 · Cited by 257 · see citing works
Heyens, L. J. M., Busschots, D., Koek, G. H., Robaeys, G., & Francque, S. (2021) · Frontiers in Medicine · doi:10.3389/fmed.2021.615978 · Cited by 243 · see citing works
Cellular Mechanisms by Which FGF21 Improves Insulin Sensitivity in Male Mice
Camporez, J. P., Jornayvaz, F. R., Petersen, M. C., Pesta, D. H., Guigni, B. A., Serr, J., Zhang, D., Kahn, M., Samuel, V. T., Jurczak, M. J., et al. (2013) · Endocrinology · doi:10.1210/en.2013-1191 · Cited by 226 · see citing works
Tillman, E. J., & Rolph, T. (2020) · Frontiers in Endocrinology · doi:10.3389/fendo.2020.601290 · Cited by 209 · see citing works
Self-citationCombination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges
Dufour, J.-F., Caussy, C., & Loomba, R. (2020) · Gut · doi:10.1136/gutjnl-2019-319104 · Cited by 193 · see citing works
van der Poorten, D., Samer, C. F., Ramezani–Moghadam, M., Coulter, S., Kacevska, M., Schrijnders, D., Wu, L. E., McLeod, D. J., Bugianesi, E., Komuta, M., et al. (2012) · Hepatology · doi:10.1002/hep.26072 · Cited by 178 · see citing works
Sanyal, A. J., Anstee, Q. M., Trauner, M., Lawitz, E. J., Abdelmalek, M. F., Ding, D., Han, L., Jia, C., Huss, R. S., Chung, C., et al. (2022) · Hepatology · doi:10.1002/hep.32204 · Cited by 171 · see citing works
Self-citationMu, J., Pinkstaff, J. K., Li, Z., Skidmore, L. K., Li, N., Myler, H. A., Dallas-Yang, Q., Hays, A. A., Yao, J., Bussell, S., et al. (2011) · Diabetes · doi:10.2337/db11-0838 · Cited by 162 · see citing works
Kim, A. M., Somayaji, V. R., Dong, J. Q., Rolph, T. P., Weng, Y., Chabot, J. R., Gropp, K. E., Talukdar, S., & Calle, R. A. (2017) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13023 · Cited by 145 · see citing works
Self-citationBone turnover: Biology and assessment tools
Szulc, P. (2018) · Best Practice & Research Clinical Endocrinology & Metabolism · doi:10.1016/j.beem.2018.05.003 · Cited by 140 · see citing works
Kaufman, A., Abuqayyas, L., Denney, W. S., Tillman, E. J., & Rolph, T. (2020) · Cell Reports Medicine · doi:10.1016/j.xcrm.2020.100057 · Cited by 131 · see citing works
Self-citationRecent Epidemiology of Nonalcoholic Fatty Liver Disease
Murag, S., Ahmed, A., & Kim, D. (2020) · Gut and Liver · doi:10.5009/gnl20127 · Cited by 121 · see citing works
Stanislaus, S., Hecht, R. I., Yie, J., Hager, T., Hall, M. P., Spahr, C. S., Wang, W., Weiszmann, J., Li, Y., Deng, L., et al. (2017) · Endocrinology · doi:10.1210/en.2016-1917 · Cited by 116 · see citing works
Chavassieux, P., Portero-Muzy, N., Roux, J.-P., Garnero, P., & Chapurlat, R. D. (2015) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2015-2957 · Cited by 99 · see citing works
Xu, P., Zhang, Y., Liu, Y., Yuan, Q., Song, L., Liu, M., Liu, Z., Yang, Y., Li, J., Li, D., et al. (2016) · Toxicology and Applied Pharmacology · doi:10.1016/j.taap.2015.11.012 · Cited by 97 · see citing works
Veidal, S. S., Vassiliadis, E., Bay‐Jensen, A., Tougas, G. H., Vainer, B., & Karsdal, M. A. (2010) · Fibrogenesis & Tissue Repair · doi:10.1186/1755-1536-3-5 · Cited by 73 · see citing works
Abdelmalek, M. F., Charles, E. D., Sanyal, A. J., Harrison, S. A., Neuschwander‐Tetri, B. A., Goodman, Z. D., Ehman, R., Karsdal, M. A., Nakajima, A., Du, S., et al. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106335 · Cited by 64 · see citing works
Self-citationFGF21 attenuates pulmonary fibrogenesis through ameliorating oxidative stress in vivo and in vitro
Zhang, S., Yu, D., Wang, M., Huang, T., Wu, H., Zhang, Y., Zhang, T., Wang, W., Yin, J., Ren, G., et al. (2018) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2018.03.100 · Cited by 62 · see citing works
Masugi, Y., Abe, T., Tsujikawa, H., Effendi, K., Hashiguchi, A., Abe, M., Imai, Y., Hino, K., Hige, S., Kawanaka, M., et al. (2017) · Hepatology Communications · doi:10.1002/hep4.1121 · Cited by 60 · see citing works
Bhattoa, H. P., Cavalier, E., Eastell, R., Heijboer, A. C., Jørgensen, N. R., Makris, K., Ulmer, C. Z., Kanis, J. А., Cooper, C. C., Silverman, S. L., et al. (2020) · Clinica Chimica Acta · doi:10.1016/j.cca.2020.12.023 · Cited by 57 · see citing works
Wu, G., Li, H., Fang, Q., Zhang, J., Zhang, M., Zhang, L., Wu, L., Hou, X., Lu, J., Bao, Y., et al. (2017) · Scientific Reports · doi:10.1038/s41598-017-05257-5 · Cited by 49 · see citing works
Recent advances in understanding and managing non-alcoholic fatty liver disease
Albhaisi, S. A. M., & Sanyal, A. J. (2018) · F1000Research · doi:10.12688/f1000research.14421.1 · Cited by 45 · see citing works
Opoku, Y. K., Liu, Z., Afrifa, J., Kumi, A. K., Liu, H., Ghartey‐Kwansah, G., Koranteng, H., Jiang, X., Ren, G., & Li, D. (2020) · EXCLI journal · doi:10.17179/excli2020-1287 · Cited by 14 · see citing works
Frías, J. P., Lawitz, E., Ortiz‐Lasanta, G., FRANEY, B. B., Morrow, L., Chen, C., Tseng, L., Charlton, R. W., Mansbach, H., Margalit, M., et al. (2021) · Journal of the Endocrine Society · doi:10.1210/jendso/bvab048.010 · Cited by 9 · see citing works
Tirucherai, G., Mora, J. R., Revankar, R., & Charles, E. D. (2019) · Journal of Hepatology · doi:10.1016/s0618-8278(19)31589-0 · Cited by 5 · see citing works
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Harrison, S. A., Frias, J. P., Neff, G., Abrams, G. A., Lucas, K. J., Sanchez, W., Gogia, S., Sheikh, M. Y., Behling, C., Bedossa, P., et al. (2023) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(23)00272-8 · Cited by 276 · see citing works
Self-citationHarrison, S. A., Rolph, T., Knott, M., & Dubourg, J. (2024) · Journal of Hepatology · doi:10.1016/j.jhep.2024.04.034 · Cited by 176 · see citing works
Self-citationObesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease?
Huttasch, M., Roden, M., & Kahl, S. (2024) · Metabolism · doi:10.1016/j.metabol.2024.155937 · Cited by 169 · see citing works
Efruxifermin in Compensated Liver Cirrhosis Caused by MASH
Noureddin, M., Rinella, M. E., Chalasani, N., Neff, G. W., Lucas, K. J., Rodriguez, M. E., Rudraraju, M., Patil, R., Behling, C. A., Burch, M., et al. (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2502242 · Cited by 144 · see citing works
Self-citationHarrison, S. A., Frías, J. P., Lucas, K. J., Reiss, G. M., Neff, G. W., Bollepalli, S., Su, Y., Chan, D. C., Tillman, E. J., Moulton, A. W., et al. (2024) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2024.02.022 · Cited by 106 · see citing works
Self-citationNoureddin, M., Frías, J. P., Neff, G. W., Lucas, K. J., Behling, C. A., Bédossa, P., Dubourg, J., Chan, D. C., Burch, M., Fong, E., et al. (2025) · The Lancet · doi:10.1016/s0140-6736(25)01073-6 · Cited by 89 · see citing works
Self-citationCurrent status and future perspectives of FGF21 analogues in clinical trials
Chui, Z. S. W., Shen, Q., & Xu, A. (2024) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2024.02.001 · Cited by 68 · see citing works
Lin, R., Sun, Q., Xin, X., Ng, C. H., Valenti, L. V. C., Hu, Y., Zheng, M., & Feng, Q. (2024) · Metabolism · doi:10.1016/j.metabol.2024.156043 · Cited by 66 · see citing works
Target Populations for Novel Triglyceride-Lowering Therapies
Nordestgaard, A. T., Tybjærg-Hansen, A., Mansbach, H., Kersten, S., Nordestgaard, B. G., & Rosenson, R. S. (2025) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2025.02.035 · Cited by 54 · see citing works
MASLD treatment—a shift in the paradigm is imminent
Machado, M. V. (2023) · Frontiers in Medicine · doi:10.3389/fmed.2023.1316284 · Cited by 51 · see citing works
Gut-liver axis: Pathophysiological concepts and medical perspective in chronic liver diseases
Rodrigues, S. G., der Merwe, V., Krag, A. A., & Wiest, R. (2024) · Seminars in Immunology · doi:10.1016/j.smim.2023.101859 · Cited by 51 · see citing works
Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH
Alkhouri, N., Beyer, C., Shumbayawonda, E., Andersson, A., Yale, K., Rolph, T., Chung, R. T., Vuppalanchi, R., Cusi, K. J., Loomba, R. S., et al. (2024) · Journal of Hepatology · doi:10.1016/j.jhep.2024.08.031 · Cited by 48 · see citing works
Self-citationFGF-based drug discovery: advances and challenges
Chen, G., Chen, L., Li, X., & Mohammadi, M. (2025) · Nature Reviews Drug Discovery · doi:10.1038/s41573-024-01125-w · Cited by 51 · see citing works
Loomba, R. S., Kowdley, K. V., Rodriguez, J., Kim, N. J., Alvarez, A. M., Morrow, L., Jeglinski, B. I., Clawson, A., Chowdhury, S. K., Bain, G., et al. (2025) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(25)00067-6 · Cited by 47 · see citing works
Pharmacological treatment of MASLD: contemporary treatment and future perspectives
Drygalski, K. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26136518 · Cited by 39 · see citing works
MetALD: Does it require a different therapeutic option?
Marek, G. W., & Malhi, H. (2024) · Hepatology · doi:10.1097/hep.0000000000000935 · Cited by 37 · see citing works
Jeong, C., Han, N., Jeon, N., Rhee, S., Staatz, C. E., Kim, M., & Baek, I. (2024) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.3278 · Cited by 36 · see citing works
Fibroblast growth factor 21 is a hepatokine involved in MASLD progression
Gallego‐Durán, R., Ampuero, J., Maya‐Miles, D., Pastor‐Ramírez, H., Montero‐Vallejo, R., Rivera‐Esteban, J., Álvarez‐Amor, L., Pareja, M. J., Rico, M. C., Millán, R., et al. (2024) · United European Gastroenterology Journal · doi:10.1002/ueg2.12534 · Cited by 35 · see citing works
A roadmap for clinical trials in MASH-related compensated cirrhosis
Pericàs, J. M., Anstee, Q. M., Augustín, S., Bataller, R. A., Berzigotti, A., Ciudin, A., Francque, S., Abraldeṣ, J. G., Hernández–Gea, V., Pons, M., et al. (2024) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-024-00955-8 · Cited by 37 · see citing works
Decoding organ fibrosis: mechanistic insights and emerging therapeutic strategies
Chen, X., Zhang, J., Guo, L., Wu, C., Zhou, J., Xu, M., Mo, L., Li, Y., & He, J. (2026) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-025-02532-0 · Cited by 37 · see citing works
Nakamura, T., Masuda, A., Nakano, D., Amano, K., Sano, T., Nakano, M., & Kawaguchi, T. (2025) · Cells · doi:10.3390/cells14060428 · Cited by 38 · see citing works
Resmetirom: The First Disease‐Specific Treatment for MASH
Mousa, A. M., Mahmoud, M., & AlShuraiaan, G. M. (2025) · International Journal of Endocrinology · doi:10.1155/ije/6430023 · Cited by 34 · see citing works
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Gilgenkrantz, H., Paradis, V., & Lotersztajn, S. (2023) · Hepatology · doi:10.1097/hep.0000000000000479 · Cited by 31 · see citing works
Potential therapeutic strategies for MASH: from preclinical to clinical development
Xie, Z., Li, Y., Cheng, L., Huang, Y., Rao, W., Shi, H., & Li, J. (2024) · Life Metabolism · doi:10.1093/lifemeta/loae029 · Cited by 31 · see citing works
Mechanism-guided drug development and treatment for liver fibrosis: a clinical perspective
Zeng, X., Huang, D., Zhu, Z., Cai, Q., Yang, Y., Lu, H., & Chen, J. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2025.1574385 · Cited by 32 · see citing works
Drapkina, O. M., Elkina, A. Y., Sheptulina, A. F., & Kiselev, A. R. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24098445 · Cited by 29 · see citing works
Abdelhameed, F., Mustafa, A., Kite, C., Lagojda, L., Dallaway, A., Than, N. N., Kassi, E. N., Kyrou, I., & Randeva, H. S. (2025) · Livers · doi:10.3390/livers5010011 · Cited by 28 · see citing works
CVOT Summit Report 2023: new cardiovascular, kidney, and metabolic outcomes
Schnell, O., Barnard-Kelly, K. D., Battelino, T., Ceriello, A., Larsson, H. E., Fernández‐Fernández, B., Forst, T. M., Frías, J. P., Gavin, J. R., Giorgino, F., et al. (2024) · Cardiovascular Diabetology · doi:10.1186/s12933-024-02180-8 · Cited by 27 · see citing works
Drug treatment for metabolic dysfunction-associated steatotic liver disease: Progress and direction
Zhou, D., & Fan, J. (2024) · Chinese Medical Journal · doi:10.1097/cm9.0000000000003355 · Cited by 25 · see citing works
Present and Future Perspectives in the Treatment of Liver Fibrosis
Cerrito, L., Galasso, L., Iaccarino, J., Pizzi, A., Termite, F., Esposto, G., Borriello, R., Ainora, M. E., Gasbarrini, A., & Zocco, M. A. (2025) · Pharmaceuticals · doi:10.3390/ph18091321 · Cited by 27 · see citing works
Puengel, T., & Tacke, F. (2023) · Expert Opinion on Investigational Drugs · doi:10.1080/13543784.2023.2230115 · Cited by 24 · see citing works
Ayesh, H., Beran, A., Suhail, S., Ayesh, S. K., & Niswender, K. D. (2024) · Biomedicines · doi:10.3390/biomedicines12102328 · Cited by 22 · see citing works
Boulos, M., Mousa, R. S., Jeries, N., Simaan, E., Alam, K., Bulus, B., & Assy, N. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26073448 · Cited by 21 · see citing works
Endoplasmic reticulum stress at the forefront of fatty liver diseases and cancer
Karin, M., & Kim, J. Y. (2025) · Pharmacological Reviews · doi:10.1016/j.pharmr.2025.100096 · Cited by 18 · see citing works
Mantovani, A., Tilg, H., & Targher, G. (2023) · Gut · doi:10.1136/gutjnl-2023-331115 · Cited by 18 · see citing works
Hormone-based pharmacotherapy for metabolic dysfunction-associated fatty liver disease
Chui, Z. S. W., Xue, Y.-Q., & Xu, A.-M. (2024) · Medical Review · doi:10.1515/mr-2024-0007 · Cited by 18 · see citing works
Jiménez, V., Sacristan, V., Jambrina, C., Jaén, M. L., Casana, E., MUÑOZ, S. A., Marcó, S., Molas, M., García, M., Grass, I., et al. (2024) · Molecular Therapy · doi:10.1016/j.ymthe.2024.10.023 · Cited by 17 · see citing works
Cheung, J., Cheung, B. M. Y., Yiu, K., Tse, H., & Chan, Y. (2025) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2025.1573841 · Cited by 15 · see citing works
Poly-Agonist Pharmacotherapies for Metabolic Diseases: Hopes and New Challenges
Allard, C., Cota, D., & Quarta, C. (2023) · Drugs · doi:10.1007/s40265-023-01982-6 · Cited by 15 · see citing works
Zhang, T., Jiang, D., Zhang, X., Chen, L., Jiang, J., Zhang, C., Li, S., & Li, Q. (2024) · Cell Communication and Signaling · doi:10.1186/s12964-024-01842-0 · Cited by 13 · see citing works
Targeting Metabolism: Innovative Therapies for MASLD Unveiled
Wang, W., Gao, X., Niu, W., Yin, J., & He, K. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26094077 · Cited by 14 · see citing works
Amoroso, M., Augustín, S., Moosmang, S., & Gashaw, I. (2024) · Journal of Molecular Medicine · doi:10.1007/s00109-024-02448-2 · Cited by 13 · see citing works
Bagherifard, A., Hemmatyar, A., Khosravi, K., Rouzbahani, A., Mokhtari, K., Yahyazedeh, H., & Tanzadehpanah, H. (2025) · International Journal of Obesity · doi:10.1038/s41366-025-01907-1 · Cited by 12 · see citing works
Lin, R., Zhou, J., Sun, Q., Xin, X., Hu, Y., Zheng, M., & Feng, Q. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17889 · Cited by 12 · see citing works
Crudele, L., García‐Irigoyen, O., Cariello, M., Piglionica, M., Scialpi, N., Florio, M., Piazzolla, G., Suppressa, P., Sabbà, C., Gadaleta, R. M., et al. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1159127 · Cited by 12 · see citing works
Ghanem, M., Archer, G., Crestani, B., & Mailleux, A. (2024) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2024.108669 · Cited by 11 · see citing works
Prevention of liver cancer in the era of next-generation antivirals and obesity epidemic
Suzuki, H., Fujiwara, N., Singal, A. G., Baumert, T. F., Chung, R. T., Kawaguchi, T., & Hoshida, Y. (2025) · Hepatology · doi:10.1097/hep.0000000000001227 · Cited by 11 · see citing works
Concepción‐Zavaleta, M. J., Fuentes‐Mendoza, J. M., Yovera, J. G. G., Ruvalcaba-Barbosa, G. Y., Cura-Rodríguez, L. D., González-Rodríguez, J. S., Urteaga, L. A. C., Pérez-Reyes, A. I., Aldave, J. E. Q., & Paz‐Ibarra, J. (2025) · World Journal of Gastroenterology · doi:10.3748/wjg.v31.i37.111435 · Cited by 11 · see citing works
Targeting THR-β for MASLD Treatment: Current Progression and Emerging Prospects
Li, J., Chen, R., Zhang, J., He, J., Wang, Y., & Li, Y. (2026) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.5c03114 · Cited by 11 · see citing works
Development of Zalfermin, a Long-Acting Proteolytically Stabilized FGF21 Analog
Sass‐Ørum, K., Tagmose, T. M., Olsen, J., Sjölander, A., Wahlund, P., Han, D., Vegge, A., Reedtz‐Runge, S., Wang, Z., Gao, X., et al. (2024) · Journal of Medicinal Chemistry · doi:10.1021/acs.jmedchem.4c00391 · Cited by 10 · see citing works
Theofilis, P., Oikonomou, E. K., Karakasis, P., Pamporis, K., Dimitriadis, K. S., Kokkou, E., Lambadiari, V., Siasos, G., Tsioufis, K. P., & Tousoulis, D. (2025) · Liver International · doi:10.1111/liv.70016 · Cited by 10 · see citing works
FGF21 Analogues and MASLD: A Summary of Preclinical and Clinical Data
Boutari, C., Triantafyllou, A., Papalavrentios, L., Goulis, I., & Sinakos, E. (2025) · Current Pharmaceutical Design · doi:10.2174/0113816128374854250709050425 · Cited by 10 · see citing works
Swamikkannu, D. M., Dasarapu, S., Siva, R. P. V., Nallam, J., & Pabba, S. (2024) · Egyptian Liver Journal · doi:10.1186/s43066-024-00331-w · Cited by 9 · see citing works
Cazac, G.-D., Lăcătușu, C.-M., Grigorescu, E.-D., Foșălău, A.-B., Onofriescu, A., & Mihai, B. M. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14041042 · Cited by 9 · see citing works
Li, S., Zou, W.-Y., Zhou, Y., Li, W., Liao, W., Li, T., & Zhang, Z.-M. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2025.1594091 · Cited by 9 · see citing works
Steatotic Liver Disease in Older Adults: Clinical Implications and Unmet Needs
Clayton‐Chubb, D., Kemp, W. W., Majeed, A., Lange, P. W., Fitzpatrick, J. A., Vaz, K., Lubel, J. S., Hodge, A. D., Ryan, J. L., McNeil, J. J., et al. (2025) · Nutrients · doi:10.3390/nu17132189 · Cited by 11 · see citing works
Nie, Z., Xu, J., Liu, Y., Cao, Q., Qiu, X., Su, Y., & Han, S. (2025) · International Journal of Endocrinology · doi:10.1155/ije/9943228 · Cited by 8 · see citing works
Kim, J., BAJAJ, H. S., Ramji, A. S., Bémeur, C., & Sebastiani, G. (2025) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2025.04.003 · Cited by 8 · see citing works
Windell, D., Magness, A. J., Beyer, C., Thomaides-Brears, H. B., Larkin, S. J., Hobson, K., Aljabar, P., Fleming, K., Fryer, E., Kendall, T. J., et al. (2025) · Journal of Clinical Pathology · doi:10.1136/jcp-2025-210311 · Cited by 7 · see citing works
Future potential therapeutics to treat MASH
Mahajan, S., Malladi, N., & Banerjee, S. K. (2025) · Drug Discovery Today · doi:10.1016/j.drudis.2025.104451 · Cited by 6 · see citing works
Abdeljawad, M. M., Hasan, M. T., Fareed, A., Abouelmagd, K., Saed, S. A. A., Ali, S., Keshk, M., Khan, M., Taha, N. A., & Taha, A. M. (2025) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/j.jpet.2025.103786 · Cited by 6 · see citing works
Kinne, A. S., Tillman, E. J., Abdeen, S. J., Johnson, D. E., Parmer, E. S., Hurst, J. P., de Temple, B., Rinker, S. D., Rolph, T., & Bowsher, R. R. (2023) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2023.115402 · Cited by 6 · see citing works
Self-citationCurrent and experimental pharmacotherapy for the management of non-alcoholic fatty liver disease
Katsarou, A., Tsioulos, G., Kassi, E. N., & Chatzigeorgiou, A. (2024) · HORMONES · doi:10.1007/s42000-024-00588-1 · Cited by 7 · see citing works
de Souza, M. H. G., Amaral, M. J. M., Lima, L. C. V., & Villela‐Nogueira, C. A. (2025) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.18498 · Cited by 6 · see citing works
Horská, K., Skrede, S., Kucera, J., Kuzmínová, G., Suchý, P., Micale, V., & Kučerová, J. (2024) · CNS Neuroscience & Therapeutics · doi:10.1111/cns.14565 · Cited by 6 · see citing works
Kamrul-Hasan, A. B. M., Borozan, S., Jena, S., Nagendra, L., Dutta, D., Bhattacharya, S., Islam, M. S., & Pappachan, J. M. (2025) · World Journal of Gastrointestinal Pharmacology and Therapeutics · doi:10.4292/wjgpt.v16.i3.110709 · Cited by 5 · see citing works
Li, D., & Zhang, X. (2025) · Hepatology Communications · doi:10.1097/hc9.0000000000000846 · Cited by 5 · see citing works
Liver cirrhosis in metabolic dysfunction-associated steatohepatitis
Ko, D., Kim, D. H., Danpanichkul, P., Nakano, M., Rattananukrom, C., Wijarnpreecha, K., Ng, C. H., & Muthiah, M. D. (2025) · Gastroenterology report · doi:10.1093/gastro/goaf037 · Cited by 5 · see citing works
Malandris, K., Papandreou, S., Vasilakou, D., Kakotrichi, P., Sarakapina, A., Kalopitas, G., Karagiannis, T., Γιουλεμέ, Ό., Bekiari, E., Liakos, A., et al. (2024) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.16559 · Cited by 4 · see citing works
Huang, Y., Liu, B., Hu, C., & Lu, Y. (2025) · Protein & Cell · doi:10.1093/procel/pwaf027 · Cited by 4 · see citing works
Self-citationAblation of histone methyltransferase Suv39h2 in hepatocytes attenuates NASH in mice
Wu, S., Ren, W., Hong, J., Yang, Y., & Lu, Y. (2024) · Life Sciences · doi:10.1016/j.lfs.2024.122524 · Cited by 4 · see citing works
Dahl, K., Friedrichsen, M. H., Ribel‐Madsen, R., Hansen, J. S., Clausen, J. O., Axelsen, M. B., Palle, M. S., Lippert, S. L., Björkdahl, O., Toubro, S., et al. (2025) · Clinical and Translational Science · doi:10.1111/cts.70435 · Cited by 3 · see citing works
Tang, M., Ma, Y., & Wang, Y. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1829315 · Cited by 3 · see citing works
How far are we from an approved drug for nonalcoholic steatohepatitis?
Méndez‐Sánchez, N., Pal, S. C., & Córdova‐Gallardo, J. (2023) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2023.2206953 · Cited by 3 · see citing works
Hakim, A., Connally, N. J., Schnitzler, G. R., Cho, M., Jiang, Z. G., Sunyaev, S. R., & Gupta, R. M. (2025) · Genes · doi:10.3390/genes16010084 · Cited by 3 · see citing works
Wang, Y., Yu, H., Cen, Z., Zhu, Y., & Wu, W. (2023) · Metabolism Open · doi:10.1016/j.metop.2023.100267 · Cited by 3 · see citing works
Armisen, J., Flor, A. W., Eriksson, J., Nelander, K., Bhattacharya, C. S., Sunnåker, M., Carter, D., Trebski, M., Gårdmark, E., Aurell, M., et al. (2025) · Liver International · doi:10.1111/liv.70406 · Cited by 3 · see citing works
Pharmacologic approach to metabolic dysfunction and related diseases: focus on liver aspects
Piazzolla, V., Napolitano, A., & Mangia, A. (2025) · Metabolism and Target Organ Damage · doi:10.20517/mtod.2025.152 · Cited by 2 · see citing works
de Oliveira, F. D., Khalil, S. M., Sato, E. D. B. D. S., de Souza, M. H. G., & Meine, G. C. (2024) · Annals of Nutrition and Metabolism · doi:10.1159/000541583 · Cited by 2 · see citing works
Huang, R., Zhang, C., Mo, X., & Rao, H. (2024) · Chinese Medical Journal · doi:10.1097/cm9.0000000000003417 · Cited by 4 · see citing works
PLAKIDA, A. L., Юшковська, О., & Sierpińska, L. E. (2026) · World Journal of Hepatology · doi:10.4254/wjh.v18.i3.113284 · Cited by 1 · see citing works
Sanyal, A. J., Abdelmalek, M. F., & Loomba, R. S. (2026) · Hepatology · doi:10.1097/hep.0000000000001734 · Cited by 1 · see citing works
Jaber, D., Jaber, I., Abulehia, A., Asad, T., & Ayesh, H. (2026) · Endocrinology Diabetes & Metabolism · doi:10.1002/edm2.70218 · Cited by 1 · see citing works
Chen, Y., Yang, X., Shen, W., Zhang, P., Yang, X., Xu, X., & Lu, D. (2026) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.70347 · Cited by 1 · see citing works
Chemoprevention in hepatocellular carcinoma
Suzuki, H., Ng, C. H., Tan, D. J. H., Teng, M. L. P., Kawaguchi, T., & Huang, D. Q. (2023) · Current Hepatology Reports · doi:10.1007/s11901-023-00614-7 · Cited by 1 · see citing works
Ayesh, H., & Olajide, O. B. (2024) · American Journal of Therapeutics · doi:10.1097/mjt.0000000000001814 · Cited by 1 · see citing works
Ali, M. H., Rehman, O. U., Talha, M., Fatima, E., Fatima, L., Zain, A., & Haisbuzzaman, M. A. (2024) · Annals of Medicine and Surgery · doi:10.1097/ms9.0000000000002649 · Cited by 1 · see citing works
Response and Adverse Event Rates With Placebo in Compensated MASH-related Cirrhosis: A Meta-analysis
Amaral, M. J. M., Moura, F. S., Lima, L. C. V., & de Souza, M. H. G. (2024) · Journal of Clinical and Experimental Hepatology · doi:10.1016/j.jceh.2024.102487 · Cited by 1 · see citing works
Wang, X., Meng, Q., Jia, A., Zhou, Y., Song, D., Ma, S., Li, W., Zhang, Z., Goldring, C. E., Feng, H., et al. (2024) · Applied Biochemistry and Biotechnology · doi:10.1007/s12010-024-05107-x · Cited by 1 · see citing works
Perspectives of Drug Therapy for Non-Alcoholic Steatohepatitis-Related Liver Fibrosis
Garbuzenko, D. V. (2025) · Fibrosis · doi:10.70322/fibrosis.2025.10002 · Cited by 1 · see citing works
Alkhouri, N., Beyer, C., Shumbayawonda, E., Andersson, A., Yale, K., Rolph, T., Chung, R., Vuppalanchi, R., Cusi, K. J., Loomba, R. S., et al. (2024) · medRxiv · doi:10.1101/2024.02.28.24302571 · Cited by 1 · see citing works
Self-citation(2023) · JHEP Reports · doi:10.1016/s2589-5559(22)00229-4
Sobral, M. V. S., Faria, H. S., Bendaham, L. C. A. R., Masiero, B. B., Gouvêa, C. A., Faria, G. D. S., dos Santos, M. D., Peres, C. D. A. P., de Oliveira, L. M., & Souto, E. B. (2025) · American Journal of Therapeutics · doi:10.1097/mjt.0000000000001868
Heiat, M., Mahmudian, M., Eisazadeh, S., Radmanesh, R., Eslamimahmoudabadi, M., & Abyazi, M. A. (2025) · Hepatitis Monthly · doi:10.5812/hepatmon-165095
Letter to the Editor: Rethinking Myeloperoxidase Inhibition in MASH —Lessons From the COSMOS Trial
Zhu, W., Li, W., Su, Y., & Zhou, W. (2025) · Liver International · doi:10.1111/liv.70432
Flor, A. W. (2025) · Liver International · doi:10.1111/liv.70479
Cutrone, A. M., Yeh, H., Uygun, K., & Usta, O. B. (2026) · Annual Review of Biomedical Engineering · doi:10.1146/annurev-bioeng-081325-053420
Wulff, A. B., Varbo, A., Nordestgaard, A. G., & Nordestgaard, B. G. (2026) · Expert Opinion on Therapeutic Targets · doi:10.1080/14728222.2026.2639678 · Cited by 2 · see citing works
Rajab, I. M., Emara, A., Elgendy, M. S., Awashra, A., Ezz, M. R., Nada, E. A., Bhullar, F. A., Cavanagh, Y., & Baddoura, W. (2026) · Hepatology International · doi:10.1007/s12072-026-11062-y
Alam, U., Rath, S., Ansab, M., Kashif, A., Sethi, F. A., Siddiqui, H. T., Afridi, Z., Burhan, M., Ali, M. A., Moiz, A., et al. (2026) · World Journal of Hepatology · doi:10.4254/wjh.v18.i3.115411
- Authors
- Harrison, S. A., Ruane, P. J., Freilich, B., Neff, G., Patil, R., Behling, C., Hu, C., Shringarpure, R., de Temple, B., Fong, E., Tillman, E. J., Rolph, T., Cheng, A., & Yale, K.
- Affiliations
- Pinnacle Clinical Research (US)
- Ruane Medical (US)
- Kansas City Research Institute (US)
- University of California San Diego (US)
- Medpace (United States) (US)
- Corresponding author
- Yale, Kitty
- ORCID
- Venue
- JHEP Reports
- Publisher
- Elsevier BV
- Published
- 2023-01
- Volume
- 5
- Issue
- 1
- Pages
- 100563
- ISSN
- 2589-5559 (ISSN-L)
- PMC
- PMC9832280
- OpenAlex
- W4292830211
- Cited by
- 110
- References
- 51
- Citations by year
- 2026: 20 · 2025: 42 · 2024: 35 · 2023: 13
- FWCI
- 16.24
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- JHEP Reports (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Health Sciences › Medicine › Hepatology › Liver physiology and pathology
- Keywords
- nonalcoholic steatohepatitis, liver fibrosis, fibrosis regression, liver injury biomarkers, PRO-C3, liver stiffness, glycolipid metabolism, alanine aminotransferase, drug safety and tolerability, SGLT2 inhibitors
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