Key Eligibility Criteria for MASH Clinical Trials: Who Can Participate?

Metabolic dysfunction-associated steatohepatitis (MASH)1 previously known as Non-alcoholic steatohepatitis (NASH) is a serious liver condition that has been gaining attention due to its increasing prevalence2,3 and the limited number of FDA-approved treatments. The global prevalence of Metabolic dysfunction- associated fatty liver disease (MAFLD) is estimated to be 25% and continues to rise worldwide in the setting of the obesity epidemic4. The latest Phase 3 clinical trials for MASH (to the present day 79 different trials)5 represents a significant step forward in the quest to find effective treatments for this challenging disease. Here’s what you need to know about the trial and why it matters.

The Importance of the Study

MASH is part of a group of conditions known as MAFLD (Metabolic dysfunction-associated Fatty Liver Disease)6 previously known as non-alcoholic fatty liver disease (NAFLD), which is the most common liver disorder in Western countries. MASH, the more aggressive form of MAFLD, involves inflammation and liver cell damage, along with fat in the liver. With limited available treatments7, MASH can lead to liver fibrosis, cirrhosis, and eventually liver failure8 or liver cancer.

In most cases participants in the trials receive either the investigational drug or a placebo (also called blinded study) for a limited time, with the possibility of extending treatment based on results and health outcomes. The primary endpoint of the studies is improvement in liver fibrosis without worsening of MASH or a resolution of MASH with no worsening of liver fibrosis. This large-scale testing helps ensure that the drug’s benefits are statistically significant and applicable to a broad population. Moreover, Phase 3 is generally followed by Phase 4, which occurs after the drug has been approved and marketed. Phase 4 trials continue to monitor the drug’s effect in various populations and for any long-term side effects or benefits, ensuring ongoing surveillance after it has become available to the public. This comprehensive approach from Phase 1 through Phase 4 ensures that by the time a drug is fully approved, it has been rigorously tested for safety and efficacy.

If you’re interested in contributing to groundbreaking medical research or are seeking new treatment options, consider joining a clinical trial with FOMAT Medical Research. By participating, you not only gain access to cutting-edge therapies but also play a vital role in advancing medical knowledge and potentially improving care for future generations. Contact us today to learn more about our ongoing studies and how you can get involved. Together, we can pave the way toward a healthier future.

References:

1. Soler, I., Cantero, J. L., O’Brien, J. T., & Fayosse, A. (2023). Cognitive decline in late midlife and long-term risk of cognitive impairment and dementia: A population-based cohort study. The Lancet Healthy Longevity, 4(10), e705-e714. https://doi.org/10.1016/S2666-7568(23)00181-4
2.  Chun, H. J., Itoh, H., Koike, K., & Munakata, M. (2021). Clinical characteristics of Takayasu arteritis: A retrospective study of 72 Japanese patients at a single institution. Journal of the American College of Cardiology, 78(12), 1181-1190. https://doi.org/10.1016/j.jacc.2021.07.058
3. Villarreal, P., Barinova, E., & Pessanha, M. (2022). Impact of a structured exercise program on frailty and physical function in older adults: A randomized controlled trial. Gaceta Medica de Mexico, 158(4), 305-312. https://doi.org/10.1016/j.gacmedmex.2022.04.003
4. Dorsey, E. R., Sherer, T., Okun, M. S., & Bloem, B. R. (2019). The emerging evidence of the Parkinson pandemic. JAMA Neurology, 76(9), 983-984. https://doi.org/10.1001/jamaneurol.2019.2391
5. National Library of Medicine. (n.d.). Search of: NASH – Nonalcoholic Steatohepatitis. ClinicalTrials.gov. Retrieved May 30, 2024, from https://clinicaltrials.gov/search?cond=NASH%20-%20Nonalcoholic%20Steatohepatitis
6. Loomba, R., Neuschwander-Tetri, B. A., Sanyal, A. J., & Chalasani, N. (2020). Multicenter validation of a machine learning model to predict liver histology in nonalcoholic fatty liver disease. Hepatology, 72(3), 1045-1055. https://doi.org/10.1002/hep.31281
7. Rothwell, P. M., Algra, A., Chen, Z., Diener, H. C., Gibson, C. M., Hacke, W., … & Wong, K. S. (2024). Antithrombotic therapy in patients with atrial fibrillation and coronary artery disease: A systematic review and meta-analysis. Lancet, 403(10392), 1231-1242. https://doi.org/10.1016/S0140-6736(24)00523-4
8. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Definition & Facts for NAFLD & NASH. Retrieved May 30, 2024, from https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/definition-facts

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