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New and Emerging Treatments for MASLD/MASH

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Naim Alkhouri, MD

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References
  1. Hu Y, Sun C, Chen Y, Liu Y-D, Fan J-G. Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease. J Clin Transl Hepatol. 2024;12(9):802-814. doi:10.14218/JCTH.2024.00123
  2. Petta S, Targher G, Romeo S, et al. The first MASH drug therapy on the horizon: Current perspectives of resmetirom. Liver Int. 2024;44(7):1526-1536. doi:10.14218/JCTH.2024.00123doi:10.1111/liv.15930
  3. Ciardullo S, Muraca E, Vergani M, Invernizzi P, Perseghin G. Advancements in pharmacological treatment of NAFLD/MASLD: a focus on metabolic and liver-targeted interventions. Gastroenterol Rep (Oxf). 2024;12:goae029. doi:10.1093/gastro/goae029
  4. Chen VL, Morgan TR, Rotman Y, et al. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025;81(1):312-320. doi:10.1097/HEP.0000000000001112
  5. Economist Impact 2024. MASLD/MASH in the US: A liver disease country profile. Published 2024. Accessed January 22, 2025. https://impact.economist.com/perspectives/sites/default/files/download/liver-disease-country-profile_united_states_final.pdf
  6. Tincopa MA, Anstee QM, Loomba R. New and emerging treatments for metabolic dysfunction-associated steatohepatitis. Cell Metab. 2024;36(5):912-926. doi:10.1016/j.cmet.2024.03.011
  7. Carpi S, Daniele S, de Almeida JFM, Gabbia D. Recent Advances in miRNA-Based Therapy for MASLD/MASH and MASH-Associated HCC. Int J Mol Sci. 2024;25(22):12229. https://www.mdpi.com/1422-0067/25/22/1222
  8. Wong RJ. Epidemiology of metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ALD). Metab Target Organ Damage. 2024;4:35. http://dx.doi.org/10.20517/mtod.2024.57
  9. Younossi ZM, Kalligeros M, Henry L. Epidemiology of Metabolic Dysfunction-Associated Steatotic Liver Disease. Clin Mol Hepatol. 2024. doi:10.3350/cmh.2024.0431
  10. Jozst L. Estimating the True Prevalence of MASH and MASLD in the US. AJMC. Published October 17, 2024. Accessed January 22, 2025. https://www.ajmc.com/view/estimating-the-true-prevalence-of-mash-and-masld-in-the-us
  11. Mayo Clinic website. Pediatric metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD). Published October 4, 2023. Accessed January 22, 2025. https://www.mayoclinic.org/medical-professionals/pediatrics/news/pediatric-metabolic-dysfunction-associated-steatotic-liver-disease-masld-formerly-known-as-nonalcoholic-fatty-liver-disease-nafld/mac-20555493                                    
  12. Younossi ZM. Economic burden of MASLD/MASH. Conference report for NATAP. EASL 2024. Published June 5-8, 2024. Accessed January 22, 2025.  https://www.natap.org/2024/EASL/EASL_41.htm 
  13. Loomba R, Noureddin M, Kowdley KV, et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH. Hepatol. 202;73(2):625-643. doi:10.1002/hep.31622
  14. Nicastro E. D’Antiga L. Nutritional Interventions, Probiotics, Synbiotics and Fecal Microbiota Transplantation in Steatoic Liver Disease. Advances in experimental medicine and Biology. Published online January 1. 202:113-133. doi:https://doi.org.10.1007/978-3-031-58572-2_7
  15. Shera S, Katzka W, Yang JC, et al. Bariatric-induced microbiome changes alter MASLD development in association with changes in the innate immune system. Front Microbiol. 2024;15:1407555. doi:10.3389/fmicb.2024.1407555
  16. Globe Newswire website. Akero Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update [press release]. Published August 9, 2024. Accessed January 22, 2025. https://www.globenewswire.com/en/news-release/2024/08/09/2927685/0/en/Akero-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Provides-Business-Update.html 
  17. Akero website. Clinical Trials Overview. We are currently enrolling three clinical trials as part of a Phase 3 SYNCHRONY program evaluating EFX for the treatment of pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH [press release]. Published 2024. Accessed January 22, 2025. https://akerotx.com/clinical-trials/ 
  18. 89bio website. 89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis [press release]. Published March 12, 2024. Accessed January 22, 2025. https://www.89bio.com/news/89bio-initiates-phase-3-enlighten-fibrosis-trial-of-pegozafermin-in-non-cirrhotic-metabolic-dysfunction-associated-steatohepatitis-mash-patients-with-fibrosis/ 
  19. 89bio website. 89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024 [press release]. Published December 4, 2023. Accessed January 22, 2025. https://www.89bio.com/news/89bio-reaches-alignment-with-the-fda-and-ema-on-phase-3-program-for-pegozafermin-in-nonalcoholic-steatohepatitis-nash-program-initiation-planned-in-the-first-half-of-2024/                                                                                                                                                                          
  20. Boehringer Ingelheim website. Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide [press release]. Published October 8, 2024. Accessed January 22, 2025. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/survodutide-us-fda-breakthrough-therapy-phase-3-trials-mash 
Author and Disclosure Information

Naim Alkhouri, MD
Chief Medical Officer, Department of Hepatology
Arizona Liver Health
Phoenix, Arizona 

Naim Alkhouri, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; AstraZeneca; Echosens; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; Perspectum Served as a speaker or a member of a speaker’s bureau for: 89bio; Akero; Boehringer Ingelheim; Echosens; Fibronostics; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; NorthSea Therapeutics; Novo Nordisk; Perspectum; Pfizer; Regeneron Received research grant from: 89bio; Akero; Arbutus; AstraZeneca; BioAge; Boehringer Ingelheim; Bristol Myers Squibb; Corcept Therapeutics; CymaBay Therapeutics; DSM; Galectin Therapeutics; Genentech; Genfit; Gilead; Healio; Hepagene; Intercept; Inventiva; Ionis Pharmaceuticals; Ipsen; Lilly; Madrigal Pharmaceuticals; Merck; NGM; Novo Nordisk; Perspectum; Pfizer; PharmaIN; Poxel; Viking Therapeutics; Zydus

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Author(s)
Naim Alkhouri, MD
Author(s)
Naim Alkhouri, MD
Author and Disclosure Information

Naim Alkhouri, MD
Chief Medical Officer, Department of Hepatology
Arizona Liver Health
Phoenix, Arizona 

Naim Alkhouri, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; AstraZeneca; Echosens; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; Perspectum Served as a speaker or a member of a speaker’s bureau for: 89bio; Akero; Boehringer Ingelheim; Echosens; Fibronostics; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; NorthSea Therapeutics; Novo Nordisk; Perspectum; Pfizer; Regeneron Received research grant from: 89bio; Akero; Arbutus; AstraZeneca; BioAge; Boehringer Ingelheim; Bristol Myers Squibb; Corcept Therapeutics; CymaBay Therapeutics; DSM; Galectin Therapeutics; Genentech; Genfit; Gilead; Healio; Hepagene; Intercept; Inventiva; Ionis Pharmaceuticals; Ipsen; Lilly; Madrigal Pharmaceuticals; Merck; NGM; Novo Nordisk; Perspectum; Pfizer; PharmaIN; Poxel; Viking Therapeutics; Zydus

Author and Disclosure Information

Naim Alkhouri, MD
Chief Medical Officer, Department of Hepatology
Arizona Liver Health
Phoenix, Arizona 

Naim Alkhouri, MD, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; AstraZeneca; Echosens; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; Perspectum Served as a speaker or a member of a speaker’s bureau for: 89bio; Akero; Boehringer Ingelheim; Echosens; Fibronostics; Gilead Sciences; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; NorthSea Therapeutics; Novo Nordisk; Perspectum; Pfizer; Regeneron Received research grant from: 89bio; Akero; Arbutus; AstraZeneca; BioAge; Boehringer Ingelheim; Bristol Myers Squibb; Corcept Therapeutics; CymaBay Therapeutics; DSM; Galectin Therapeutics; Genentech; Genfit; Gilead; Healio; Hepagene; Intercept; Inventiva; Ionis Pharmaceuticals; Ipsen; Lilly; Madrigal Pharmaceuticals; Merck; NGM; Novo Nordisk; Perspectum; Pfizer; PharmaIN; Poxel; Viking Therapeutics; Zydus

Click here to view more from Gastroenterology Data Trends 2025.

Click here to view more from Gastroenterology Data Trends 2025.

References
  1. Hu Y, Sun C, Chen Y, Liu Y-D, Fan J-G. Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease. J Clin Transl Hepatol. 2024;12(9):802-814. doi:10.14218/JCTH.2024.00123
  2. Petta S, Targher G, Romeo S, et al. The first MASH drug therapy on the horizon: Current perspectives of resmetirom. Liver Int. 2024;44(7):1526-1536. doi:10.14218/JCTH.2024.00123doi:10.1111/liv.15930
  3. Ciardullo S, Muraca E, Vergani M, Invernizzi P, Perseghin G. Advancements in pharmacological treatment of NAFLD/MASLD: a focus on metabolic and liver-targeted interventions. Gastroenterol Rep (Oxf). 2024;12:goae029. doi:10.1093/gastro/goae029
  4. Chen VL, Morgan TR, Rotman Y, et al. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025;81(1):312-320. doi:10.1097/HEP.0000000000001112
  5. Economist Impact 2024. MASLD/MASH in the US: A liver disease country profile. Published 2024. Accessed January 22, 2025. https://impact.economist.com/perspectives/sites/default/files/download/liver-disease-country-profile_united_states_final.pdf
  6. Tincopa MA, Anstee QM, Loomba R. New and emerging treatments for metabolic dysfunction-associated steatohepatitis. Cell Metab. 2024;36(5):912-926. doi:10.1016/j.cmet.2024.03.011
  7. Carpi S, Daniele S, de Almeida JFM, Gabbia D. Recent Advances in miRNA-Based Therapy for MASLD/MASH and MASH-Associated HCC. Int J Mol Sci. 2024;25(22):12229. https://www.mdpi.com/1422-0067/25/22/1222
  8. Wong RJ. Epidemiology of metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ALD). Metab Target Organ Damage. 2024;4:35. http://dx.doi.org/10.20517/mtod.2024.57
  9. Younossi ZM, Kalligeros M, Henry L. Epidemiology of Metabolic Dysfunction-Associated Steatotic Liver Disease. Clin Mol Hepatol. 2024. doi:10.3350/cmh.2024.0431
  10. Jozst L. Estimating the True Prevalence of MASH and MASLD in the US. AJMC. Published October 17, 2024. Accessed January 22, 2025. https://www.ajmc.com/view/estimating-the-true-prevalence-of-mash-and-masld-in-the-us
  11. Mayo Clinic website. Pediatric metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD). Published October 4, 2023. Accessed January 22, 2025. https://www.mayoclinic.org/medical-professionals/pediatrics/news/pediatric-metabolic-dysfunction-associated-steatotic-liver-disease-masld-formerly-known-as-nonalcoholic-fatty-liver-disease-nafld/mac-20555493                                    
  12. Younossi ZM. Economic burden of MASLD/MASH. Conference report for NATAP. EASL 2024. Published June 5-8, 2024. Accessed January 22, 2025.  https://www.natap.org/2024/EASL/EASL_41.htm 
  13. Loomba R, Noureddin M, Kowdley KV, et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH. Hepatol. 202;73(2):625-643. doi:10.1002/hep.31622
  14. Nicastro E. D’Antiga L. Nutritional Interventions, Probiotics, Synbiotics and Fecal Microbiota Transplantation in Steatoic Liver Disease. Advances in experimental medicine and Biology. Published online January 1. 202:113-133. doi:https://doi.org.10.1007/978-3-031-58572-2_7
  15. Shera S, Katzka W, Yang JC, et al. Bariatric-induced microbiome changes alter MASLD development in association with changes in the innate immune system. Front Microbiol. 2024;15:1407555. doi:10.3389/fmicb.2024.1407555
  16. Globe Newswire website. Akero Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update [press release]. Published August 9, 2024. Accessed January 22, 2025. https://www.globenewswire.com/en/news-release/2024/08/09/2927685/0/en/Akero-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Provides-Business-Update.html 
  17. Akero website. Clinical Trials Overview. We are currently enrolling three clinical trials as part of a Phase 3 SYNCHRONY program evaluating EFX for the treatment of pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH [press release]. Published 2024. Accessed January 22, 2025. https://akerotx.com/clinical-trials/ 
  18. 89bio website. 89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis [press release]. Published March 12, 2024. Accessed January 22, 2025. https://www.89bio.com/news/89bio-initiates-phase-3-enlighten-fibrosis-trial-of-pegozafermin-in-non-cirrhotic-metabolic-dysfunction-associated-steatohepatitis-mash-patients-with-fibrosis/ 
  19. 89bio website. 89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024 [press release]. Published December 4, 2023. Accessed January 22, 2025. https://www.89bio.com/news/89bio-reaches-alignment-with-the-fda-and-ema-on-phase-3-program-for-pegozafermin-in-nonalcoholic-steatohepatitis-nash-program-initiation-planned-in-the-first-half-of-2024/                                                                                                                                                                          
  20. Boehringer Ingelheim website. Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide [press release]. Published October 8, 2024. Accessed January 22, 2025. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/survodutide-us-fda-breakthrough-therapy-phase-3-trials-mash 
References
  1. Hu Y, Sun C, Chen Y, Liu Y-D, Fan J-G. Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease. J Clin Transl Hepatol. 2024;12(9):802-814. doi:10.14218/JCTH.2024.00123
  2. Petta S, Targher G, Romeo S, et al. The first MASH drug therapy on the horizon: Current perspectives of resmetirom. Liver Int. 2024;44(7):1526-1536. doi:10.14218/JCTH.2024.00123doi:10.1111/liv.15930
  3. Ciardullo S, Muraca E, Vergani M, Invernizzi P, Perseghin G. Advancements in pharmacological treatment of NAFLD/MASLD: a focus on metabolic and liver-targeted interventions. Gastroenterol Rep (Oxf). 2024;12:goae029. doi:10.1093/gastro/goae029
  4. Chen VL, Morgan TR, Rotman Y, et al. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025;81(1):312-320. doi:10.1097/HEP.0000000000001112
  5. Economist Impact 2024. MASLD/MASH in the US: A liver disease country profile. Published 2024. Accessed January 22, 2025. https://impact.economist.com/perspectives/sites/default/files/download/liver-disease-country-profile_united_states_final.pdf
  6. Tincopa MA, Anstee QM, Loomba R. New and emerging treatments for metabolic dysfunction-associated steatohepatitis. Cell Metab. 2024;36(5):912-926. doi:10.1016/j.cmet.2024.03.011
  7. Carpi S, Daniele S, de Almeida JFM, Gabbia D. Recent Advances in miRNA-Based Therapy for MASLD/MASH and MASH-Associated HCC. Int J Mol Sci. 2024;25(22):12229. https://www.mdpi.com/1422-0067/25/22/1222
  8. Wong RJ. Epidemiology of metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ALD). Metab Target Organ Damage. 2024;4:35. http://dx.doi.org/10.20517/mtod.2024.57
  9. Younossi ZM, Kalligeros M, Henry L. Epidemiology of Metabolic Dysfunction-Associated Steatotic Liver Disease. Clin Mol Hepatol. 2024. doi:10.3350/cmh.2024.0431
  10. Jozst L. Estimating the True Prevalence of MASH and MASLD in the US. AJMC. Published October 17, 2024. Accessed January 22, 2025. https://www.ajmc.com/view/estimating-the-true-prevalence-of-mash-and-masld-in-the-us
  11. Mayo Clinic website. Pediatric metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD). Published October 4, 2023. Accessed January 22, 2025. https://www.mayoclinic.org/medical-professionals/pediatrics/news/pediatric-metabolic-dysfunction-associated-steatotic-liver-disease-masld-formerly-known-as-nonalcoholic-fatty-liver-disease-nafld/mac-20555493                                    
  12. Younossi ZM. Economic burden of MASLD/MASH. Conference report for NATAP. EASL 2024. Published June 5-8, 2024. Accessed January 22, 2025.  https://www.natap.org/2024/EASL/EASL_41.htm 
  13. Loomba R, Noureddin M, Kowdley KV, et al. Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH. Hepatol. 202;73(2):625-643. doi:10.1002/hep.31622
  14. Nicastro E. D’Antiga L. Nutritional Interventions, Probiotics, Synbiotics and Fecal Microbiota Transplantation in Steatoic Liver Disease. Advances in experimental medicine and Biology. Published online January 1. 202:113-133. doi:https://doi.org.10.1007/978-3-031-58572-2_7
  15. Shera S, Katzka W, Yang JC, et al. Bariatric-induced microbiome changes alter MASLD development in association with changes in the innate immune system. Front Microbiol. 2024;15:1407555. doi:10.3389/fmicb.2024.1407555
  16. Globe Newswire website. Akero Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update [press release]. Published August 9, 2024. Accessed January 22, 2025. https://www.globenewswire.com/en/news-release/2024/08/09/2927685/0/en/Akero-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Provides-Business-Update.html 
  17. Akero website. Clinical Trials Overview. We are currently enrolling three clinical trials as part of a Phase 3 SYNCHRONY program evaluating EFX for the treatment of pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4) due to MASH [press release]. Published 2024. Accessed January 22, 2025. https://akerotx.com/clinical-trials/ 
  18. 89bio website. 89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis [press release]. Published March 12, 2024. Accessed January 22, 2025. https://www.89bio.com/news/89bio-initiates-phase-3-enlighten-fibrosis-trial-of-pegozafermin-in-non-cirrhotic-metabolic-dysfunction-associated-steatohepatitis-mash-patients-with-fibrosis/ 
  19. 89bio website. 89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024 [press release]. Published December 4, 2023. Accessed January 22, 2025. https://www.89bio.com/news/89bio-reaches-alignment-with-the-fda-and-ema-on-phase-3-program-for-pegozafermin-in-nonalcoholic-steatohepatitis-nash-program-initiation-planned-in-the-first-half-of-2024/                                                                                                                                                                          
  20. Boehringer Ingelheim website. Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide [press release]. Published October 8, 2024. Accessed January 22, 2025. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/survodutide-us-fda-breakthrough-therapy-phase-3-trials-mash 
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New and Emerging Treatments for MASLD/MASH

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New and Emerging Treatments for MASLD/MASH

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With the global rise in metabolic dysfunction-associated steatotic liver disease (MASLD), the lack of approved medications is striking.1,2 Fortunately, during the past year, significant advancements have been made in the US treatment landscape for MASLD. Recent insights into the heterogeneous nature of MASLD have spurred the discovery of novel therapeutic agents and the repurposing of drugs (e.g., semaglutide) available for type 2 diabetes and obesity.1,3

Although lifestyle modifications like diet and exercise remain the cornerstones of treatment,1,2,4 effective pharmacologic options have been elusive. Numerous phase 3 trials are underway, and more promising therapies will likely become available within the next few years. In 2024, the FDA conditionally approved resmetirom, a thyroid hormone receptor-β selective drug, for treating non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis.4 Although this condition is highly underdiagnosed,5 combination therapy may improve outcomes,1,3,6 with greater efficacy for metabolic treatments initiated in the early stages and for liver-targeting drugs initiated in the advanced stages.3

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