As prevalence of obesity increases, so do the major complications of the resulting metabolic syndrome, including nonalcoholic steatohepatitis (NASH). NASH is fast becoming the leading cause of liver failure today and is a daunting societal health threat in terms of morbidity and mortality. And, as with pre-diabetes, patients with NASH are asymptomatic until late in the disease course.
With more pharmaceutical products pursuing the NASH indication, strategic and logistical expertise in the indication are critical to clinical development planning for these products. Issues like liver biopsy-based endpoints, physiologic and behavioral risk factors, typically long treatment durations, variable diagnostics, and complex regulatory precedence compound the complexity. That’s why we are continually looking at better trial design options and more effective ways to screen patients for NASH trials.
Chiltern has an experienced team of gastroenterology trial design and logistics professionals, including thought leaders in NASH. Our medical professionals are familiar with the science and treatment of the inter-related complications of NASH. Our GI team wants to support and add value to your product. Whether you are in planning or ready to start trials, let’s talk about how we can apply our medical, scientific, operational and regulatory talents to further your product success.
Causal Etiology of Lifestyle Metabolic Disease
This etiology diagram covers about 93 percent of NASH not attributable to drug-related or hepatotoxins injury (obesity-related NAFLD). Since this percentage of NASH is obesity-related, it seems wise to consider this etiology as a primary focus in product development planning for the NASH indication.
- Overweight, obesity
- Muscle atrophy
- Abdominal obesity
- Waist-hip ratio > 1
- Genetic predispositions may accelerate specific progression paths
- Elevated CVD risk
- Chronic inflammation
- Insulin resistance
- Ectopic adiposity
- CVD events
- Type 2 diabetes
- Vascular disease
- NAFLD, NASH, Cirrhosis