Obesity is a leading cause of death and is increasingly common in adults and children. One of the risk factors associated with the condition is a fat accumulation in the liver (hepatic steatosis) which affects around 25% of Europeans. The presence of hepatic steatosis has been shown to affect drug metabolism. This has raised questions over the inclusion of volunteers with liver abnormalities in clinical trials.
We identify predictive factors for hepatic steatosis in clinical trial volunteers to help improve volunteer screening and mitigate the risks of confounding variables impacting the quality of trial data and results.
In a recent prospective longitudinal study, we found that routine measurements such as BMI and abnormal liver function tests are not adequate to ensure that volunteers with hepatic steatosis won’t get admitted to clinical trials to avoid misleading results.
Our research also uncovers how changes in dietary composition can influence the detection of hepatotoxicity and false negative results during phase I clinical trials of new chemical entities.
The hepatology unit at the Richmond Research Institute is led by Professor Kevin Moore.