• Pauline Lavigne

NASH and Obesity Trials: Parts 1 and 2

Thursday, December 3rd: 5:30 – 7:30 pm and 8:00 – 9:30 pm


Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD), and it is closely related to obesity and diabetes. Unfortunately the symptoms are often silent or non-specific, and as a result, many patients may not be diagnosed until late stages of the disease. The session on non-alcoholic steatohepatitis (NASH) and obesity trials will be conducted in two parts.


The first session “Changing Paradigm” will be chaired by gastroenterologists Dr. Stephen Harrison, the Medical Director of Pinnacle Clinical Research in San Antonio, TX, USA, and Dr. Arun Sanyal, the Education Core Director at the Virginia Commonwealth University's Center for Clinical and Translational Research in Richmond, VA, USA.


This session will explore the role of insulin resistance in driving increased CV risk in these patients, and whether different NASH phenotypes are associated with CV risk. We will discuss current and future NASH drugs and trials, as well as GLP-1 receptor agonists, and obesity trials. The evolving trial endpoints and the role of artificial intelligence and noninvasive testing in the future should generate a lot of discussion. Frank Anania and Lisa Yanoff from the US FDA will discuss the evolving guidance surrounding removing the requirement for CV outcome trials (CVOTs) from the 2020 FDA diabetes guidance.

Joining the co-chairs are Naveed Sattar (Glasgow, Scotland), Stephen Harrison (San Antonio, USA), Benjamin Scirica (Boston, USA), Barry Borlaug (Minneapolis, USA), Michael Chatlton (Chicago, USA), and Muthiah Vaduganathan (Boston, USA).


Enhancing the presentations will be a moderated, multi-stakeholder, expert panel debate focusing on clinically meaningful endpoints in NASH and obesity trials which will include additional researchers as well various industry representatives.


Our co-chairs, Dr. Harrison, and Dr. Sanyal will be sticking around for a second session on NASH, called “Multi Stakeholders’ Forum”. We hope you will hang in there as well.

This session will build on what we learned in the first session, but provide a multidisciplinary look at NASH and obesity. We will hear from a statistician (Beth Davison, Momentum Research), a hepatologist, a cardiologist (Muthiah Vaduganathan, Boston, USA), a diabetologist (Julio Rosenstock, Dallas, USA), an obesity specialist (Donna Ryan, Baton Rouge, USA), and our patient, Steve Macari (Poitiers, FRA). Participants from a variety of pharmaceutical and biotechnology companies will also provide multiple industry perspectives. Following the main presentations, additional researchers and regulatory agency representatives will join the presenters for a moderated, multi-stakeholder, expert panel debate. For a complete update on NASH and obesity, this two-part session is definitely not to be missed.

The Future of HFrEF Trials

Monday, December 7th: 1:30 – 3:30 pm Therapy for heart failure with reduced ejection fraction (HFrEF) is constantly evolving. Despite the use of beta blockers, ACEIs, ARBs, sacubutril/valsartan, miner

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