Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH)
NAFLD and NASH: A Global
Health Challenge
The global prevalence of non-alcoholic fatty liver disease (NAFLD) – a precursor to non-alcoholic steatohepatitis (NASH) and a risk factor for liver cirrhosis and hepatocellular carcinoma (HCC) – is alarmingly high, especially in patients with certain lifestyle and health risks. At CRS, we understand the significant clinical impact of these metabolic disorders.
Despite extensive research, there are currently no approved drugs to prevent or treat NAFLD/NASH. That is why CRS, in collaboration with leading institutions, has initiated multiple initiatives to combat these conditions.
NAFLD Increases Overall Mortality by Up to 60 Percent
The worldwide prevalence of NAFLD has surpassed 25 percent among adults, with rates climbing to 70-80 percent in obese or Type 2 diabetic individuals. NAFLD increases overall mortality by up to 60 percent, primarily due to liver-related mortality and cardiovascular complications.
When hepatic inflammation and fibrosis worsen, 30-40 percent of NAFLD cases progress to NASH, further heightening the risk of liver cirrhosis or HCC. Consequently, NAFLD and NASH have become leading causes of liver-related morbidity and mortality.
In Western countries, a sedentary lifestyle, obesity, adipose tissue dysfunction, insulin resistance, and Type 2 diabetes are major risk factors for NAFLD. It is also considered the hepatic manifestation of metabolic syndrome.
NAFLD development is more common in individuals with metabolic syndrome, and progression to NASH with increased inflammation and fibrosis is more likely. Dysfunctional adipose tissue, lipotoxicity, inflammation, and the release of hepatokines, adipokines, and inflammatory cytokines are key factors in the progression from NAFLD to NASH.
NAFLD/NASH Prevention and Treatment: Promising Candidates With No Approved Drug Treatment
Recent research has made significant strides in understanding the pathophysiology of NAFLD and developing strategies to prevent or treat NAFLD/NASH. While lifestyle interventions have shown high efficacy in clinical trials, maintaining these changes in real-world settings is challenging.
To date, no pharmacological treatments for NAFLD/NASH have been approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Although Vitamin E and PPAR-gamma agonists have shown promise in smaller trials, their impact on NAFLD/NASH treatment is limited.
Intensive basic research has identified several promising molecular signaling pathways for pharmacological interventions in NAFLD/NASH. Incretin-based treatments and SGLT-2 inhibitors, approved for Type 2 diabetes, have shown beneficial effects in obese Type 2 diabetic patients with NAFLD/NASH.
New drugs under clinical evaluation include dual or pan PPAR agonists, apoptosis signal-regulating kinase 1 (ASK1) inhibitors, fibroblast growth factor 21 (FGF21) analogs, C-C chemokine receptor types 2 and 5 (CCR2/CCR5) agonists, farnesoid X receptor (FXR) agonists, acetyl-CoA carboxylase inhibitors, and modifications of the intestinal microbiome.
Our Initiatves to Combat NAFLD/NASH
- Transient liver elastography (FibroScan®)
- MRI-derived proton density fat fraction (MRI-PDFF)
- Liver biopsy and histology
- Laboratory biomarkers such as Cytokeratin 18 (CK 18) and Soluble CD 163 (sCD 163) Adipokines and cytokines
- NAFLD/NASH scores including BARD-Score, NAFLD-Score, Fibrosis 4 Score, and Fatty Liver Index
- Metabolomic and proteomic analyses
- RNA and micro-RNA epigenetic factors
Addressing the Nafld and Nash Crisis:
Our Commitment to Global Health Solutions
At CRS, we are dedicated to tackling the NAFLD and NASH crisis with innovative solutions and expert support.
Our comprehensive database of volunteers and patients, along with our network of leading medical specialists and family doctors, ensures that we can effectively recruit both healthy volunteers and patients with cardiovascular conditions for your NAFLD and NASH clinical trials. This robust infrastructure enables us to meet your recruitment needs efficiently and with high-quality candidates.
In addition, our state-of-the-art Early-Phase Clinical Trial Units are designed to meet the highest standards and ensure full compliance with FDA and EMA regulations. Our meticulous approach guarantees that every NAFLD and NASH trial we manage is conducted with the utmost precision and adherence to regulatory requirements.
By collaborating with prestigious external clinical centers, we offer a comprehensive range of services that span from preclinical research to advanced proof-of-concept trials. Our experienced team of scientists, project managers, and medical writers supports you throughout the trial process, from designing effective study protocols to analyzing results and preparing scientific publications.
Our proven success, demonstrated by numerous publications in leading international journals, underscores our commitment to advancing NAFLD and NASH research.
Reach out today to contribute to significant discoveries that benefit patients worldwide.