Comprehensive Expertise in Metabolic Testing
Our customers benefit from Celerion’s comprehensive knowledge of specialized metabolic testing methods and hands-on operational experience that supports early Proof-of-Concept in the development of diabetes, obesity, nd metabolic dysfunction associated steatohepatitis (MASH) therapies. We help you explore potential solutions for your drug development program. Whether your investigational target has a body weight reduction, anti-fibrosis or improved cardiovascular risk indication, Celerion delivers key pharmacodynamic endpoints to successfully support your early clinical studies. We have conducted hundreds of studies and thousands of procedures ensuring robust study designs are developed for optimal success. This experience ensures that we are able to anticipate potential issues and address them to deliver high-quality data within your study timeline. Celerion’s experience includes a number of metabolic disease indications such as diabetes, NAFLD/MASH and obesity to name a few.
With over a decade of expertise in metabolic diseases ensures the highest standards are applied for the design, conduct and analysis of all studies. Our team has hands-on experience with a wide range of testing procedures and models to detect early signals of safety or efficacy that support better decision making and delivery of efficient drug development programs for you. Specifically, our in-depth knowledge of diabetes and obesity studies ensures best practices are applied, to provide high-quality data that adheres to FDA and EMA guidelines to support regulatory filings.
Key to the conduct of any clinical study is an effective recruitment strategy of healthy subjects and target patient populations. Celerion has an expansive active database of over 128,000 healthy subjects, metabolic syndrome, prediabetes participants as well as Type I and II diabetes patients. Through partnering with local and national community and health-based organizations we have gained further access to patient populations, speeding the recruitment and start-up of your study.
To support NAFLD/MASH drug programs, Celerion offers our clients on-site, cutting edge, non-invasive technology to measure liver fat (steatosis) and stiffness (fibrosis). The FibroScan® is an ultrasound-like system that quickly and simultaneously captures hepatic steatosis and stiffness; these measurements can be incorporated into a study as part of pre-screening efforts, inclusion criteria as well as exploratory endpoints.
Traditional drug development defers the detection of signals for efficacy to late phase. Celerion leverages complex predictive models that allow signals of safety and efficacy to be detected in an early phase setting, empowering clients to make better decisions earlier in the drug development process. Anti-diabetic drug development is also burdened with mandated late phase cardiovascular risk assessments. Celerion provides our customers with an early phase solution for de-risking potential failure of a compound in late phase due to CV risk assessment allowing for the early detection of cardiovascular risk signal, enabling better decision making earlier in the drug development process.
The FibroScan® Advantage in Early MASH Clinical Studies
Metabolic dysfunction associated steatotic liver disease (MASLD), formerly known as NAFLD is a chronic disorder characterized by excess fat within the liver. Metabolic dysfunction associated steatohepatitis (MASH), also known as NASH, is a more severe form of the disease in which hepatic steatosis is accompanied by inflammation and injury to liver cells. This can lead to fibrosis, cirrhosis, end-stage liver disease and even hepatocellular carcinoma.