NASH (Non-Alcoholic Steatohepatitis) is becoming increasingly prevalent worldwide and threatens to put an even greater burden on healthcare systems, but what will it mean for clinical trials in the future?
The condition NASH affects millions of people globally, paralleling the rising rates of obesity, type 2 diabetes and metabolic syndrome. Currently there are no approved pharmacological therapies specifically for NASH, with lifestyle modifications such as weight loss and exercise the only recommended measures for managing the condition.
NASH imposes a substantial and growing economic burden on healthcare systems due to its associated complications which include hospitalisations, liver transplants, and long-term management of cirrhosis and liver cancer. In the US, NASH is the most rapidly increasing indication for liver transplants1. Research into effective treatments for NASH therefore has a huge potential to reduce healthcare costs and improve patient outcomes.
Dr Laura Alba, medical director of hepatology for Saint Luke’s Liver Disease Management Center (US), has said that research into treatments is vital, particularly for NASH patients who have inflammation and liver damage – which puts them at risk of developing cirrhosis2.
According to a recent review by BMJ3, non-alcoholic fatty liver disease (NAFLD) – of which NASH is an advanced form – affects at least a quarter of the global population. The same review highlighted some of the areas researchers are likely to target in the near future in an effort to find a treatment for NASH. These include the development of drugs that reduce fibrosis, and combinations of drugs which enable targeting of metabolic dysfunction and liver damage.
At present, despite a number of drugs in various stages of research, only a few have entered phase 3, and outcomes sufficient for full regulatory approval may still be some years away.
Other research is targeting lifestyle and nutritional factors such as the effect of ultra-processed food and drink which accounts for up to 60 per cent of total daily energy intake in some countries. There are already trials assessing the role of fats and carbohydrates on liver fat content, and the benefits of a Mediterranean diet in combatting NASH.
It’s likely that in the future, evidence-based advice on diet and exercise will be used alongside drug therapies to lower the incidence of NASH – and clinical trials across the population will be key to making these a reality.
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