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The tribulations of conducting NASH trials

Designing clinical trials for the treatment of NASH is challenging. The pathogenesis of this disease is poorly understood and is probably multifactorial. A trial of a phosphodiesterase-4 inhibitor produced negative results, despite promising preclinical data. Examining why this trial failed might help us design better trials of treatments for NASH in the future.

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Figure 1: Developing therapeutic agents for NASH is challenging because of uncertainty about which abnormalities are the best targets.

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Correspondence to Brent A. Neuschwander-Tetri.

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B.A.N.-T. acts as an advisor for Boehringer-Ingelheim, Genentech/Roche and Nimbus, and was an advisor for Astellas when trials of ASP9831 were being considered in 2010–2011.

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Neuschwander-Tetri, B. The tribulations of conducting NASH trials. Nat Rev Gastroenterol Hepatol 11, 274–276 (2014). https://doi.org/10.1038/nrgastro.2014.51

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