Lessons Learned from Completed Trials in NAFLD/NASH, PBC and PSC

The first pivotal study in NASH was posted on clinicaltrials.gov only three years ago. Now, five Phase III trials are underway with one- and two-year Phase II data already published or communicated. These trials have helped shape and refine approaches in trial design, patient identification and operational conduct, which are key factors for enabling more efficient trials in the future. In the case of Primary Biliary Cholangitis (PBC), it took nearly two decades after the approval of ursodeoxycholic acid (UDCA) before a second drug, obeticholic acid (OCA), was approved. However, it is unlikely that the development of additional therapies will be as protracted. Currently, one compound is in Phase III and several others are being evaluated in Phase II trials. In this webinar, we discuss key lessons learned in clinical development over the past three years in NAFLD, PBC and PSC.